Reported Jun 15, 2022 · Terminated
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Medacta USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medacta Usa Inc · 3973 Delp St · Memphis, TN · 38118-6110
Is this the product you have?
- GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
- Lot codes and dates
- Model Number/Reference Code11.01041
- UDI-DI07630971252509
- Lot Numbers Lots
2109258 (exp. 06/24/2026)2111198 (exp. 10/04/2026)2115530 (exp. 10/27/2026)
- Amount recalled
- 50 units
Where it was sold
Why it was recalled
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
This product could cause temporary or reversible health problems — stop using it.
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