FDA Device recall Z-0306-2020
TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 004…
- FDA Device
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 004… 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-0306-2020 |
| 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
TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600
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-0306-2020%22
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