FDA Device recall Z-0322-2020
Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 0059790…
- FDA Device
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 0059790… by Zimmer Biomet, citing non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0322-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-10 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148
Reason
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Identifiers
| code_info | All product manufactured prior to January 2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0322-2020%22
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