GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Check against the official notice below — it lists the full affected range.
Medacta USA Inc. is recalling 50 units of GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 due to a manufacturing error in which a Size 2 trial baseplate was assembled with Size 1 instrument sets. The affected products were distributed to hospitals and medical facilities in Alaska, California, Connecticut, Indiana, Massachusetts, New Jersey, and Pennsylvania. The recalled instruments are identified by Model Number 11.01041, UDI-DI 07630971252509, and lot numbers 2109258, 2111198, and 2115530.
The source document does not specify what actions affected consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
A Size 2 trial baseplate was assembled with Size 1 instrument sets.
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. Quantity: 50 units 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.