FDA recall Z-1653-2023

Product

TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E

Reason for recall

Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

Distribution

US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan

Key facts

Status

Ongoing

Initiation date

2023-04-13

Report date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1653-2023