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.
Stryker neurovascular has become aware that some units of target nano product do not have the intended
stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Acción
Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
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.
Stryker neurovascular has become aware that some units of target nano product do not have the intended
stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Acción
Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
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.
Stryker neurovascular has become aware that some units of target nano product do not have the intended
stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Acción
Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
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.
Stryker neurovascular has become aware that some units of target nano product do not have the intended
stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Acción
Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
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.
Stryker neurovascular has become aware that some units of target nano product do not have the intended
stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Acción
Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
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.
Stryker neurovascular has become aware that some units of target nano product do not have the intended
stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Acción
Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
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.
Stryker neurovascular has become aware that some units of target nano product do not have the intended
stretch resistance. the sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Acción
Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated June 3, 2016, to all affected customers via FED Ex. Letter includes recall letter, list of impacted lot numbers, customer acknowledgement form and frequently asked questions. Customers were instructed to immediately check their inventory. segregate the effected inventory in a secure location for return to Stryker, circulate the Field Safety Notice internally to all interested/affected parties. Inform Stryker if any of the subject devices have been distributed to other organizations. Customers were also instructed to complete the attached customer response form and return the completed form to their nominated Stryker Representative.
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 firm discovered on march 4, 2016 that several product codes were inadvertently left off of hold 1503.
Acción
On April 26, 2016 DePuy Synthes sent a letter informing their customers of the recall.
ACTION REQUIRED
Our records show that your facility has received one or more of product(s) subject to the recall (correction). The Anspach
Effort, Inc. asks that you:
1) There is no requirement for retaining your inventory of Gl Dissection Tools.
2) To ensure Gl Cutting Tool & Attachment compatibility, please reference Table 1 to review which Attachments are
compatible. The Cutting TooVAttachment combination noted with a check mark in Table I will function as intended.
The Cutting Tool/Attachment combinations noted with an "X" in Table 1 will not secure effectively and should not be
used.
3) Review, complete, sign and return the attached reply form confirming your receipt of this letter by fax or email details
provided on the form. Returning the form promptly will prevent you from receiving repeat notices.
1. Share this letter with others in your facility that needs to be made aware of this recall (correction).
2. If you distribute any of the product(s) subject to the recall (correction) to other services or facilities, please forward
this letter as appropriate immediately.
3. Keep a copy of this notice with the product(s) subject to the recall (correction).
If you have any questions regarding this correction, please contact the Complaint Handling Unit Manager at 561-494-3673
or contact your Anspach Sales Representative.
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.
In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. because of these false high readings were displayed in the lower measuring range from 0 to 20 mmhg.
the observed measurement error was particularly at the lowest end of the range (to 0 mmhg) up to 8 mmhg.
Acción
Spiegelberg Gmbh & Co. KG sent an Urgent Medical Device Recall letter dated December 29, 2009, to all affected customers. Customers were instructed to quarantine and return stored products.
Furthermore, they were asked to inform all their customers which have received the affected products and recall the products accordingly. Furthermore, they were asked to tell us about the actions taken by them.
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
Motor, drill, electric - Product Code HBC
Causa
The graphics at the attachment interface indicating locked and unlocked position are reversed.
Acción
The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE-RECALL (Removal)" letter dated June 15, 2016 to its customers. The letter described the product, problem and actions to taken. The customers were instructed to review your inventory and immediately remove the product subject to this recall from stock; If you DO HAVE any of the identified devices, please take the following steps:
" Ensure anyone in your facility impacted by this notification reads this letter carefully.
Customer Letter Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating product subject to the recall has been located. Indicate the number of devices found.
" The RMA information has been filled in for your convenience.
" Please include your name, title, address, telephone number, signature and date in the spaces provided.
" Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Department by:
" Fax: (561) 627-2682
" Scan/email: DPYUS-PowerToolsFieldActions@its.jnj.com
" Giving it to your DePuy Synthes Sales Consultant.
" This return documentation acknowledges your receipt of medical device removal information.
" Return the affected product to your DePuy Synthes Sales Consultant
" Keep this notice visibly posted for awareness until all products subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this action and keep a copy for your records.
If you DO NOT HAVE the identified product, please take the following steps:
" Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Include your name, title, address, telephone number, signature and date in the spaces provided.
" Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Department by Fax: (561) 627-2682
" Scan/email: DPYUS-PowerToolsFiel
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
Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Causa
Medtronic has voluntarily decided to retrieve unused model 3387s-40 and 3389s-40 dbs leads from three manufacturing lot numbers.
during the manufacturing process of a dbs lead component, medtronic identified the potential for lead insulation damage.
Acción
Consignees were delivered in person by Medtronic Field Representatives a "Medical Device Removal" letter dated June 2016. The letter described the problem and the product involved in the recall. Advised consignees to return the unused product and to complete the Customer Confirmation Form. For questions contact Medtronic Technical Services at 800-707-09033 weekdays 7 am - 6 pm, or contact your Medtronic representative.
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
Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Causa
Due to the potential for pocket adaptor conductor wire fractures involving dbs pocket adaptor model 64001 and model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.
Acción
Consignees were sent on 6/23/2016 a "Medical Device Safety Notification," dated June 2016. The letter was addressed to Healthcare Professional. The letter described "Background" information on the problem and product involved in the recall. It also provided "Recommendations" which included "Implanting the pocket adaptor with the neurostimulator" and "Checking system integrity".
For questions contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - 6pm CST.
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
Probe, radiofrequency lesion - Product Code GXI
Causa
Mismatch between the length of the rf electrode (probe) and the cannula (introducer),.
Acción
All distributors and healthcare facilities that were directly shipped recalled devices were notified of the recall beginning 6/16/2016 by email and by FedEx. They were instructed to examine their stock and to quarantine and discontinue use of the product. The letter contained a response form which was to faxed back to Halyard.
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.
Stryker instruments initiated a voluntary recall of specific lots of round fluted burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.
Acción
Stryker initiated a voluntary recall of the Stryker Round Fluted Burs (used with Stryker CORE" System) on June 16, 2016, via certified mail due to the potential for the devices to have tarnishing or corrosion present.
Non-responding accounts will be contacted by phone, email, and/or fax as necessary in an effort to obtain signed Business Reply Forms. Affected product will be removed from the field. Further corrective and preventative actions will be determined through the associated CAPA. The existing label will be defaced, packaging will be opened and products will be destroyed.
Actions to be taken by the Customer/User:
1. Immediately review this Recall Notification.
2. Check all stock areas and/or operating room storage to determine how many affected Round Fluted Burs from the affected lots are at your facility. Quarantine and discontinue use of the recalled Round Fluted Burs.
3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand.
Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification.
4 If you have further distributed this product, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF.
5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762.
6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account.
Report any serious adverse events or product quality problems to Stryker Instruments: 1-800-253-3210 Health care professionals and consumers
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.
Stryker instruments initiated a voluntary recall of specific lots of round fluted burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating surgical intervention.
Acción
Stryker initiated a voluntary recall of the Stryker Round Fluted Burs (used with Stryker CORE" System) on June 16, 2016, via certified mail due to the potential for the devices to have tarnishing or corrosion present.
Non-responding accounts will be contacted by phone, email, and/or fax as necessary in an effort to obtain signed Business Reply Forms. Affected product will be removed from the field. Further corrective and preventative actions will be determined through the associated CAPA. The existing label will be defaced, packaging will be opened and products will be destroyed.
Actions to be taken by the Customer/User:
1. Immediately review this Recall Notification.
2. Check all stock areas and/or operating room storage to determine how many affected Round Fluted Burs from the affected lots are at your facility. Quarantine and discontinue use of the recalled Round Fluted Burs.
3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand.
Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification.
4 If you have further distributed this product, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF.
5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762.
6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account.
Report any serious adverse events or product quality problems to Stryker Instruments: 1-800-253-3210 Health care professionals and consumers
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.
A variation in flute depth on the routers was observed. the variation in flute depth may cause the routers to be
more susceptible to breakages.
risk to health:
injury to critical soft tissue requiring surgical intervention may occur.
Acción
Stryker sent an Urgent Medical Device Recall Notification letter dated June 24, 2016, to the affected customers via courier, and to Sales Representatives and international affiliates via e-mail. 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. For questions regarding this recall, please contact Stryker Instruments at 269-389-2921.
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.
Medtronic navigation, inc. announces a voluntary field action for the axiem touch n go pointer probe because the patient registration accuracy may compromise navigation accuracy when using the stealthstation¿ system with touch n go pointer probes for patient registration.
Acción
The firm, Medtronic, sent an "URGENT: MEDICAL DEVICE RECALL" letter on 12/12/16 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine inventory for any affected products, quarantine them for return to Medtronic; complete and return the CUSTOMER RESPONSE FORM by email at RS.NavFCA@medtronic.com or fax to Medtronic Technical Services at 651-367-7075 (even if you do not have affected product); and contact Medtronic Technical Services at 1-800-595-9709 to get a return material authorization (RMA) and arrange for their return and no charge replacements.
If you have any questions regarding this communication, please contact Medtronic Technical Services at (800) 595-9709.
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.
Integra lifesciences has been notified of a medical device recall by adaptive surgical, llc involving their riverlon" nylon 3-0 sutures that are packaged in integras cranial access kits. it was found that product seals may become open during extreme distribution conditions and render the device unsterile.
Acción
Consignees notified on August 12, 2016 via letter to identify and return product.
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
Shunt, central nervous system and components - Product Code JXG
Causa
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Acción
Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
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
Shunt, central nervous system and components - Product Code JXG
Causa
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Acción
Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
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
Shunt, central nervous system and components - Product Code JXG
Causa
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Acción
Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
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
Shunt, central nervous system and components - Product Code JXG
Causa
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Acción
Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
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
Shunt, central nervous system and components - Product Code JXG
Causa
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Acción
Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
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
Shunt, central nervous system and components - Product Code JXG
Causa
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Acción
Integra sent an "Urgent Voluntary Medical Device Recall" Letter and Recall Acknowledgement and Return Form dated August 23, 2016 to their affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was advised if they have distributed the product to identify those customers and forward a copy of the enclosed Integra Medical Device Voluntary Recall Notification to those customers. The customer was also asked to review their inventory for the affected product and complete the attached form indicating whether or not they have any of the affected product in their inventory. Customers with questions were instructed to contact Customer Service at 1-800-654-2873.
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.
Product code l- 7b-g1 was inadvertently released off of hold status and the affected products were distributed.
Acción
On April 26, 2016 DePuy Synthes sent a letter informing their customers of the recall.
ACTION REQUIRED
Our records show that your facility has received one or more of product(s) subject to the recall (correction). The Anspach
Effort, Inc. asks that you:
1) There is no requirement for retaining your inventory of Gl Dissection Tools.
2) To ensure Gl Cutting Tool & Attachment compatibility, please reference Table 1 to review which Attachments are
compatible. The Cutting TooVAttachment combination noted with a check mark in Table I will function as intended.
The Cutting Tool/Attachment combinations noted with an "X" in Table 1 will not secure effectively and should not be
used.
3) Review, complete, sign and return the attached reply form confirming your receipt of this letter by fax or email details
provided on the form. Returning the form promptly will prevent you from receiving repeat notices.
1. Share this letter with others in your facility that needs to be made aware of this recall (correction).
2. If you distribute any of the product(s) subject to the recall (correction) to other services or facilities, please forward
this letter as appropriate immediately.
3. Keep a copy of this notice with the product(s) subject to the recall (correction).
If you have any questions regarding this correction, please contact the Complaint Handling Unit Manager at 561-494-3673
or contact your Anspach Sales Representative.