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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

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.
Recall Number Z-2130-2013
Classification Class II
Code Info Catalog #6541-2-609 All lot codes
Product Distributed Qty 10,537 units
Reason For Recall Stryker Orthopaedics has received complaints associated with cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.

Event Detail

Event Id 65902
Product Type Devices
Status Ongoing
Recalling Firm Stryker Howmedica Osteonics Corp.
City Mahwah
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution