FDA recall Z-2069-2025

Product

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

Reason for recall

Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

Distribution

US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.

Key facts

Status

Ongoing

Initiation date

2025-05-23

Report date

2025-07-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cirencester, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2069-2025