Recall Z-2130-2013— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-2130-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-02

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2013-07-02, terminated 2016-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.. Reason: Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-07-02
Terminated: 2016-04-27
Firm location: Mahwah, NJ, United States

Product description

Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.

Reason for recall

Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.

Data sourced from openFDA. This site is unofficial and independent of the FDA.