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Biomet Hip System recallZ-1008-2018 · Zimmer Biomet, Inc. · initiated Sep 15, 2017

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 piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.

FDA root cause category: Error in labeling

What the company is doing

Foreign risk managers were emailed notification of recall with the following instructions: 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 product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. 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 transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].

Recall details

Recall number
Z-1008-2018
Status
Terminated
Initiated by the company
Sep 15, 2017
Recalling firm
Zimmer Biomet, Inc.
Quantity
23
Product code
JDI
FDA submissions
K032396
Distribution
Outside USA

Product description

36MM COCR MODULAR HD -6MM

Code information (models, lots, serial numbers)

11-363660 UDI Number: (01) 00880304210509 (17) 270507 (10) 236840  Product Number: 11-363660 Lot Number: 236840

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

10 devices cleared under K032396 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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