medical Class II Updated 2022-06-15

Medacta Usa Inc recalls GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Recalled Product

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1


Hazard / Issue

A Size 2 trial baseplate was assembled with Size 1 instrument sets.

Issued by

FDA

Affected States: AK, CA, CT, IN, MA, NJ, PA
Lot/Code Info: Model Number/Reference Code: 11.01041; UDI-DI: 07630971252509; Lot Numbers Lots: 2109258 (exp. 06/24/2026), 2111198 (exp. 10/04/2026), 2115530 (exp. 10/27/2026)
View official government recall

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