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.
Other recalls by Medacta Usa
- Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.…
FDA Device · Class II · 2026-07-08 · Medacta Usa - MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa - MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
FDA Device · Class II · 2023-04-26 · Medacta Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1247-2022%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.