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U.S. Department of Health and Human Services

Class 2 Device Recall GMK Efficiency GMK Sphere CR Insert Instrument Set Size 1

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  Class 2 Device Recall GMK Efficiency GMK Sphere CR Insert Instrument Set Size 1 see related information
Date Initiated by Firm April 13, 2022
Create Date June 07, 2022
Recall Status1 Terminated 3 on October 23, 2023
Recall Number Z-1247-2022
Recall Event ID 90074
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Code Information 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)  
Recalling Firm/
Manufacturer		 Medacta Usa Inc
3973 Delp St
Memphis TN 38118-6110
For Additional Information Contact Customer Service
312-878-2381
Manufacturer Reason
for Recall		 A Size 2 trial baseplate was assembled with Size 1 instrument sets.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 50 units
Distribution Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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