Recall Z-1247-2022— Medacta Usa Inc
Class II · Terminated
Class II FDA medical device recall by Medacta Usa Inc, initiated 2022-04-13, terminated 2023-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1. Reason: A Size 2 trial baseplate was assembled with Size 1 instrument sets..
- Recalling firm
- Medacta Usa Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-04-13
- Terminated
- 2023-10-23
- Firm location
- Memphis, TN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.