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Biomet Knee System recallZ-2177-2018 · Zimmer Biomet, Inc. · initiated May 18, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.

FDA root cause category: Under Investigation by firm

What the company is doing

On May 18, 2018, the firm notified affected distributors and user facilities of the recall through Urgent Medical Device Recall letters sent via email and FedEx. The letters informed affected consignees of the issue and stated that the affected units were distributed in March 2018. 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. Complete Attachment 1 Inventory Return Certification Form and send to [email protected] within three (3) days. b. For each return, send a copy of Attachment 1 to [email protected]. 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 [email protected]. 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. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected

Recall details

Recall number
Z-2177-2018
Status
Terminated
Initiated by the company
May 18, 2018
Posted by the FDA
Jun 1, 2018
Recalling firm
Zimmer Biomet, Inc.
Quantity
16
Product code
JWH
FDA submissions
K010212, K142933, K171054, K915132
Distribution
US Distribution to the states of : FL, GA, IN, MA, NM, UT, and WI. Foreign distribution to Canada and Mexico

Product description

Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty

Code information (models, lots, serial numbers)

Lot 385340  UDI: (01) 00880304005310 (17) 280306 (10) 385340

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

213 devices cleared under K010212, K142933, K171054, K915132 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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