Howmedica Osteonics Corp.: Medical Device Recall in 2021 - (Recall #: Z-1186-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 10, 2021

Date Posted: March 17, 2021

Recall Number: Z-1186-2021

Event ID: 87350

Reason for Recall:

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.

Status: Terminated

Product Quantity: 11 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated