FDA Device recall Z-1247-2022
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
- FDA Device
- Class II
- terminated
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 by Medacta Usa, citing A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1247-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-13 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medacta Usa |
| Distribution | AK, CA, CT, IN, MA, NJ, PA |
Product
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Reason
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Identifiers
| code_info | Model Number/Reference Code: 11.01041; UDI-DI: 07630971252509; Lot Numbers Lots: 2109258 (exp. 06/24/2026), 2111198 (exp. 10/04/2026), 2115530 (exp. 10/27/2026) |
|---|
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-1247-2022%22
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