Z-1247-2022 Class II Terminated
FDA device recall Z-1247-2022 was initiated by Medacta Usa Inc on April 13, 2022 and is designated Class II. Reason for recall: A Size 2 trial baseplate was assembled with Size 1 instrument sets. The recall status is terminated (terminated October 23, 2023). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2022
- Initiation Date
- April 13, 2022
- Termination Date
- October 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Reason for Recall
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Distribution Pattern
Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
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)