FDA recall Z-2329-2021

Product

Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

Reason for recall

The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.

Distribution

Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.

Key facts

Status

Terminated

Initiation date

2021-07-01

Report date

2021-08-25

Termination date

2023-05-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2329-2021