Device product
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Z-1247-2022
Product summary
- Firm
- Medacta Usa Inc
- Event
- Event 90074
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-1247-2022
Official wording
Reason: A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Code information: 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)
Distribution pattern: Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
A Size 2 trial baseplate was assembled with Size 1 instrument sets.