FDAClass IINovember 13, 2019

Various temporary devices used during the implantation recall

Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments…

Why was Various temporary devices used during the implantation recalled?

Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All products manufactured prior to January 2014.

Product
Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments…
Recalling firm
Zimmer Biomet, Inc.
Quantity
5,459,583 total devices
Distribution
Distributed nationwide.
Recall date
November 13, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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