medical Class II Updated 2021-03-17

Howmedica Osteonics Corp. recalls Prosthesis, knee, patello/femorotibial, semi-constrained, un

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV
Lot/Code Info: Catalogue # 5536-B-400, Lot Number CTD44301
View official government recall

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