FDA recall Z-1247-2022

Product

GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

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.

Key facts

Status

Terminated

Initiation date

2022-04-13

Report date

2022-06-15

Termination date

2023-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1247-2022