GMK Sphere CR Size 1 Instrument Set Assembly Defect Recall
Medacta Usa Inc recalls GMK Sphere CR Insert Instrument Set Size 1 due to component assembly error: Size 2 trial baseplates were assembled with Size 1 instrument sets, potentially affecting surgical function.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a surgical instrument assembly defect where Size 2 baseplates were assembled with Size 1 instrument sets. Although no illnesses or injuries have been reported, the component mismatch poses a risk of harm by affecting surgical instrument function and fit.
Plain-English summary
Medacta Usa Inc is recalling the GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1. This surgical instrument set is used in orthopedic procedures. Fifty units of this device have been recalled.
The recall was initiated because Size 2 trial baseplates were incorrectly assembled with Size 1 instrument sets. This component mismatch could affect the proper function and fit of the instruments during surgery.
The recalled instruments were distributed to healthcare facilities in Alaska, California, Connecticut, Indiana, Massachusetts, New Jersey, and Pennsylvania. The affected lot numbers are 2109258 (expiration 06/24/2026), 2111198 (expiration 10/04/2026), and 2115530 (expiration 10/27/2026).
Healthcare providers and facilities should immediately cease use of affected units and contact Medacta Usa Inc for return or replacement of the recalled instruments.
The recalled product
- Product
- GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
- Manufacturer
- Medacta Usa Inc
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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)
Distribution
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