FDA-Device2021-08-25Class II

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

Howmedica Osteonics Corp.
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.

Sold states
Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.
Affected count
14 US; 2 OUS
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

Official notice

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

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