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Terminated

Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE

FDA Recall Z-0964-2013 · Posted 2013-03-18

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2013-01-24
Date Terminated2015-05-06
Product Quantity4 units (total of 2 sets)

Reason for Recall

The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.

Firm Action

A Notification Letter/Product Accountability Form dated 01/28/2013 was sent via FedEx on 01/28/2013 to the sole US branch receiving the affected devices. The branch was instructed to also contact the hospitals in its territory that have the affected product to arrange return of the product. Affected products to be returned to Stryker Orthopaedics, 325 Corporate Drive, Mahway, NJ 07430.

Root Cause

Process design

Distribution Pattern

1 Branch (NJ) with one consignee (DE).

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053514TRIATHLON TOTAL KNEE SYSTEMStryker Orthopaedics · 2006-01-26

Official Source

View FDA Recall →

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

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