Medacta Usa Inc: Medical Device Recall in 2022 - (Recall #: Z-1247-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

Product Classification:

Class II

Date Initiated: April 13, 2022

Date Posted: June 15, 2022

Recall Number: Z-1247-2022

Event ID: 90074

Reason for Recall:

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

Status: Terminated

Product Quantity: 50 units

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)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated