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Recall Observatory FDA recall evidence

Device product

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

Z-2329-2021

July 01, 2021

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 88422
Status
Terminated
Classification
Class II
Quantity
14 US; 2 OUS
Official record key
device-enforcement:Z-2329-2021

Official wording

Reason: 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.

Code information: Lot JHS2H

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.