Home / Recalls / Medical Devices
Howmedica Osteonics Corp. recalls Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Recalled August 25, 2021 · FDA recall Z-2329-2021 · Howmedica Osteonics
Hazard
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. · FDA Class II
Units
14 US; 2 OUS
Sold at
Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.
Description
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.
Product
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →