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Terminated

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

FDA Recall Z-1186-2021 · Posted None

Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMBH
Date Initiated2021-02-10
Date Terminated2023-05-30
Product Quantity11 devices

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.

Firm Action

On 2/11/2021, Stryker issued Urgent Medical Device Recall notices to customers via UPS 2-day air stating Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123486TRIATHLON TRITANIUM TIBIAL BASEPLATEStryker · 2013-05-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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