FDA Device recall Z-0622-2021
M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures
- FDA Device
- Class II
- terminated
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures by Biomet, citing specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0622-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-25 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet |
| Distribution | US |
Product
M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.
Reason
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Identifiers
| code_info | Lot number 832990 |
|---|
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-0622-2021%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.