U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Causa
Some eyelets broke from swivelock anchor on insertion.
Acción
On March 24, 2017, Arthrex contacted all distributors that received potentially affected device and instructed them to place the product in quarantine. On March 27th, 2017, Distributors were instructed to return the affected device to Arthrex. Call Arthrex Customer Service at 855-552-5056 for returned goods authorization (RGA) and product return instruction. Please complete the Recall Acknowledge of Receipt postal card included in the notification. Any questions contact Complaints@Arthrex.comor 866-267-9138
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Causa
Some eyelets broke from swivelock anchor on insertion.
Acción
On March 24, 2017, Arthrex contacted all distributors that received potentially affected device and instructed them to place the product in quarantine. On March 27th, 2017, Distributors were instructed to return the affected device to Arthrex. Call Arthrex Customer Service at 855-552-5056 for returned goods authorization (RGA) and product return instruction. Please complete the Recall Acknowledge of Receipt postal card included in the notification. Any questions contact Complaints@Arthrex.comor 866-267-9138
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer - Product Code HRY
Causa
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Acción
On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Distributors, Sales Representatives, and Distributor Operation Managers
Your Responsibilities:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks.
a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type.
b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
d. Clearly mark RECALL on the outside of return boxes.
5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Acción
On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Distributors, Sales Representatives, and Distributor Operation Managers
Your Responsibilities:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks.
a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type.
b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
d. Clearly mark RECALL on the outside of return boxes.
5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Acción
On February 17, 2017 URGENT MEDICAL DEVICE RECALL (REMOVAL) - LOT SPECIFIC notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Distributors, Sales Representatives, and Distributor Operation Managers
Your Responsibilities:
1. Review this notification and ensure affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks.
a. Request a Return Authorization Number via email to rgarequest@zimmerbiomet.com or through FAST/SMS. Specify RECALL as the RGA type.
b. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 with your shipment for immediate processing.
d. Clearly mark RECALL on the outside of return boxes.
5. Hospitals that received direct shipments of the affected products from Zimmer Biomet will be sent a copy of the Risk Manager Recall Notice directly. Surgeons will also be notified. It is important that you review the list of hospitals and surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice, return contact information for any additional hospitals and surgeons that may have received or used the affected product. If there are no additional
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Screw, fixation, bone - Product Code HWC
Causa
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Acción
Smith & Nephew sent an Urgent Medical First Recall Notice dated March 9, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested the quarantine and return of the devices, and for the distributors to notify their consignees and ensure the same actions. International consignees were notified by email. Consignees with questions were instructed to contact FieldAction@smith-nephew.com.
For questions regarding this recall call 978-749-1440.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Screw, fixation, bone - Product Code HWC
Causa
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Acción
Smith & Nephew sent an Urgent Medical First Recall Notice dated March 9, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested the quarantine and return of the devices, and for the distributors to notify their consignees and ensure the same actions. International consignees were notified by email. Consignees with questions were instructed to contact FieldAction@smith-nephew.com.
For questions regarding this recall call 978-749-1440.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Screw, fixation, bone - Product Code HWC
Causa
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Acción
Smith & Nephew sent an Urgent Medical First Recall Notice dated March 9, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested the quarantine and return of the devices, and for the distributors to notify their consignees and ensure the same actions. International consignees were notified by email. Consignees with questions were instructed to contact FieldAction@smith-nephew.com.
For questions regarding this recall call 978-749-1440.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Plate, fixation, bone - Product Code HRS
Causa
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Acción
Smith & Nephew sent an Urgent Medical First Recall Notice dated March 9, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested the quarantine and return of the devices, and for the distributors to notify their consignees and ensure the same actions. International consignees were notified by email. Consignees with questions were instructed to contact FieldAction@smith-nephew.com.
For questions regarding this recall call 978-749-1440.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Voluntary recall/removal of panta and panta xi nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.
Acción
Integra sent "Urgent Medical Device Recall Letters and Return Response Forms" dated March 3, 2017 to their distributors and customers.
All customers were asked to examine their inventory to determine if they had the recalled lots and if they did they are instructed to stop using them immediately. Distributors are asked if the recalled product was further distributed, those customers should be notified and instructed to follow the recalling procedures. The return response form should be completed, even if they do not have any recalled lots, annotating the amount of product and list a record of the lot numbers. The return response form should be sent back to Integra via email to: FCA2@integralife.com or via fax to: 1-609-750-4220. Upon receipt by Integra, if your company has identified recalled lots, Customer Service will contact the customer and provide an RMA number and directions to return the product, as well as input an order to replace the quantity indicated on the return response form.
Should any customer have any questions regarding the recall instructions, they can contact Customer Service at 1-800-654-2873. To return units under field inventory, customer can contact 1-888-601-0203, option 2.
For further questions, please call (717) 309-3966.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The dovetails of poly trials, beta 2.0, were observed as either cracked or broken.
Acción
Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The dovetails of poly trials, beta 2.0, were observed as either cracked or broken.
Acción
Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The dovetails of poly trials, beta 2.0, were observed as either cracked or broken.
Acción
Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The dovetails of poly trials, beta 2.0, were observed as either cracked or broken.
Acción
Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Acción
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Acción
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Acción
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Acción
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Acción
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Acción
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Acción
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Acción
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Acción
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
Zimmer biomet inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Acción
Zimmer Biomet initiated a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Zimmer Biomet sent letters via Fed-Ex and e-mail dated 02/28/2017 to customers informing them of the recall, and instructing them to do the following:
1. Review this notification and ensure affected team members are aware of the contents.
2. Complete the Certification of Acknowledgement portion of Attachment 1
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three
(3) days.
3. Assist the Zimmer Biomet sales representative quarantine all affected product.
4. If after reviewing this notice customers have further questions or concerns, please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an oncall representative in the case of an emergency. Alternatively, questions may be sent by
email to corporatequality.postmarket@zimmerbiomet.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
¿ MedWatch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by mail, or by fax.
¿ Online: www.fda.gov/medwatch/report.htm
¿ Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm
¿ Fax: 1-800-FDA-0178
Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing zimmer.per@zimmerbiomet.com.
For questions regarding this recall call 574-371-3071.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Causa
This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content.
information was disseminated to distributors and sales representatives during the 2016 national sales meeting held february 17-21, 2016.
Acción
Zimmer Biomet sent an Urgent Medical Device Correction Notice dated July 7, 2016, to all consignees on the list requiring them to destroy all literature and notify Zimmer Biomet of others who they have disseminated the material further. Retraining the sales force on the use of the TM Ardis. The details of the strategy are contained within the Draft Recall Strategy attached to the email transmitting this report. For further questions, please call (973) 576-0032.