FDA Device recall Z-2363-2020
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
- FDA Device
- Class II
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class II recall of Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003 by Biomet, citing device and tray that houses the device did not pass steam sterilization process validation testing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2363-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-01 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet |
| Distribution | US |
Product
Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003
Reason
Device and tray that houses the device did not pass steam sterilization process validation testing
Identifiers
| code_info | All lots |
|---|
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-2363-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.