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FDAFebruary 10, 2021device

Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.

What to do

FDA enforcement status: Terminated

Brands named

howmedica osteonicshowmedica

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer. — Recall Details · AllClear