Zimmer Biomet, Inc. recalls Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bit…
- Recall date
- October 10, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0329-2020
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- Distributed nationwide.
Why it was recalled
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Various temporary devices used during the implantation of the device system: bone fixation plates and screws, drill bits, manual surgical instruments for general use. Item Nos. 0202024301 0202024325 0202024330 0202024342 0202024344 0202024346 0202024360 0202024362 47225806700
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