GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Reported: June 15, 2022 Initiated: April 13, 2022 #Z-1247-2022
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.
Details
- Recalling Firm
- Medacta Usa Inc
- Units Affected
- 50 units
- Distribution
- Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1. Recalled by Medacta Usa Inc. Units affected: 50 units.
Why was this product recalled? ▼
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 15, 2022. Severity: Moderate. Recall number: Z-1247-2022.
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