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.
Two lots of different sized modular heads potentially commingled. risks include delay in surgery and dislocation due to use of an incorrect sized head.
Acción
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 4/2/2018 to its customers. The letter described the product, problem and actions to be taken. Distributors will be notified of the recall via email. Hospital risk managers and distributors with product will be notified via courier. The distributor letter includes instructions to locate and remove the product in their territory, identify hospitals who have previously used the product; return on-hand product to the recalling firm and ensure all products are accounted for. The letter for hospital risk managers instruct the risk managers to assist the recalling firm's sales reps with quarantine of the product; to review notification and ensure affected personnel are aware of the contents; and complete and return the Certificate of Acknowledgement form to CorporateQuality.PostMarket@zimmerbiomet.com, even if you do not have product, and retain a copy.
Customers with questions are directed to call customer service at 574-371-3071 between 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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.
Two lots of different sized modular heads potentially commingled. risks include delay in surgery and dislocation due to use of an incorrect sized head.
Acción
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 4/2/2018 to its customers. The letter described the product, problem and actions to be taken. Distributors will be notified of the recall via email. Hospital risk managers and distributors with product will be notified via courier. The distributor letter includes instructions to locate and remove the product in their territory, identify hospitals who have previously used the product; return on-hand product to the recalling firm and ensure all products are accounted for. The letter for hospital risk managers instruct the risk managers to assist the recalling firm's sales reps with quarantine of the product; to review notification and ensure affected personnel are aware of the contents; and complete and return the Certificate of Acknowledgement form to CorporateQuality.PostMarket@zimmerbiomet.com, even if you do not have product, and retain a copy.
Customers with questions are directed to call customer service at 574-371-3071 between 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
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
There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall letters to their affected customers. The letters identified the affected product, problem and the actions to be taken.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. For each return, complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days.
b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com.
c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
d. Mark RECALL on the outside of the returned cartons.
4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.
a. Review the list of hospitals and/or surgeons included with the email notification sent to your facility, which includes a list of hospitals and/or surgeons that have already been notified of this recall.
b. Identify whether there are any additional hospitals and/or surgeons that Zimmer Biomet has not notified and list these accounts on the Additional Accounts form. Please provide the form in Excel format.
c. If there are no additional accounts or surgeons to notify, please indicate that there are no additional accounts, or indicate None or NA on the form.
5. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility.
6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transf
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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
Firm is is conducting a voluntary recall of the rival reduce fracture plating system and rival view plating system. as the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
Acción
On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
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 single lot of genesis ii femoral five degree valgus bushing due to a laser mark labeling error. the left valgus bushing was incorrectly laser marked as right and vice versa.
Acción
The firm sent an Urgent Medical Device Recall Notice dated April 9, 2018.
Required Actions:
1. Please inspect your inventory and locate any unused devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately.
a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out.
2. If you have no product to return, please put an X in the appropriate location below.
3. If you have product to return, please list the batch numbers and quantities of each batch that you are returning in the appropriate boxes below.
4. Complete the remainders of the form sign and send to FieldActions@smith-nephew.com or fax to 901-566- 7975.
Please Note even if you have no product to return, this form must be completed, signed and returned.
5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number.
If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com. For further questions, please 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
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Causa
Omega lif interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
Acción
The firm initiated the recall by letter on April 16, 2018, The firm requested return of the product. Distributors who further distributed the product were directed to notify their customers. For further questions, please call (760) 607-1812.