Medacta Usa Inc GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Brand
Medacta Usa Inc
Lot Codes / Batch Numbers
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)
Products Sold
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)
Medacta Usa Inc is recalling GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 due to A Size 2 trial baseplate was assembled with Size 1 instrument sets.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, CA, CT, IN, MA, NJ, PA
Page updated: Jan 10, 2026