CLASS II Device recall · Reported 15 Jun 2022 · FDA Enforcement Report

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size recalled

Medacta Usa is recalling GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1, distributed in 7 states. The recall was initiated on 13 Apr 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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)

Quantity recalled50 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1247-2022
FDA event ID: 90074
Recalling firm: Medacta Usa, Memphis, TN
Classification: Class II
Status: Terminated
Recall initiated: 13 Apr 2022
FDA classified: 7 Jun 2022
Reported: 15 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Apr 2022	Recall initiated by company
7 Jun 2022	Classified by FDA	+55 days
15 Jun 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Where it was distributed

Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.

Alaska California Connecticut Indiana Massachusetts New Jersey Pennsylvania

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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)

Where was it sold?

Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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