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Medacta Usa Inc recalls GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Recalled June 15, 2022 · FDA recall Z-1247-2022 · Medacta Usa
Hazard
A Size 2 trial baseplate was assembled with Size 1 instrument sets. · FDA Class II
Units
50 units
Sold at
Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
Description
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Product
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Manufacturer(s)
Medacta Usa Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →