FDA Device

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Hazard

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

What You Should Do

Remedy

The recalling firm emailed their sales agents on 4/13/2022 to notify them the implants were associated with a recall and must be returned immediately to the recalling firm. It also said that replacements are currently on order and will be overnighted to them once they are available. A copy of the Field Safety Notice from the manufacturer was forwarded to the sales agents. The Notice informed them the three affected lots have been assembled following an incorrect packing list, resulting in a size 2 trial baseplate being inserted in a size 1 instrument set, and that all the other devices included in the packing list and instrument set are correct.

Products

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Brand
Medacta Usa Inc
UPC
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)

Units Affected

50 units