GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
- Company
- Medacta Usa Inc
- Recall Initiated
- April 13, 2022
- Terminated
- October 23, 2023
- Recall Number
- Z-1247-2022
- Quantity
- 50 units
- Firm Location
- Memphis, TN
Reason for Recall
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
Distribution
Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
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)
Root Cause
Nonconforming Material/Component
Action Taken
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.