Medacta Usa Inc Recall 90074
Description: GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Medacta Usa Inc Recall 90074 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1247-2022 |
| Event ID | 90074 |
| Event Description | GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 |
| Product Type | Devices |
| Distribution | Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution. |
| Quantity | 50 units |
| Recall Reason | A Size 2 trial baseplate was assembled with Size 1 instrument sets. |
| Device Classification | 20220615 |
| Device 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) |
| Center Classification Date | 20220607 |
| Recall Initiation Date | 20220413 |
| Recalling Firm | Medacta Usa Inc |
| Initial Notification | |
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