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Recall Observatory FDA recall evidence

Device product

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

Z-1186-2021

February 10, 2021

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 87350
Status
Terminated
Classification
Class II
Quantity
11 devices
Official record key
device-enforcement:Z-1186-2021

Official wording

Reason: 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.

Code information: Catalogue # 5536-B-400, Lot Number CTD44301

Distribution pattern: Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.