FDA-Device2022-06-15Class II
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Medacta Usa Inc
Hazard
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Sold states
Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
Affected count
50 units
Manufactured in
3973 Delp St, Memphis, TN, United States
Products
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1247-2022Don't want to check this manually?
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