Knee Instruments recallZ-1247-2022 · Medacta Usa Inc · initiated Apr 13, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medacta Usa Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1247-2022
- Status
- Terminated
- Initiated by the company
- Apr 13, 2022
- Recalling firm
- Medacta Usa Inc
- Quantity
- 50 units
- Product code
- LXH
- Distribution
- Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.
Product description
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Code information (models, lots, serial 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)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Knee Instruments 11.01041Medacta International SA · Orthopedic Manual Surgical Instrument1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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