FDA Device recall Z-0487-2022
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
- FDA Device
- Class II
- terminated
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class II recall of GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 by Depuy Orthopaedics, citing stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0487-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-07 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Reason
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Identifiers
| code_info | Lot #: 9809673 GTIN: 10603295004097 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0487-2022%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.