Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures.
FDA Recall Z-1619-2009 · Posted 2009-07-15
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-05-15
Date Terminated2010-04-05
Product Quantity26
Reason for Recall
The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.
Firm Action
Stryker Orthopaedics issued an "Urgent Product Correction" notice dated May 15, 2009 via Federal Express addressed to Branch/Agency Manager/Quality Contact informing them of the affected device. The letter outlined instructions for correction and requested consignees to complete and return a Product Correction Acknowledgment Form by fax to 1-201-831-6069.
Questions can be directed to Colleen O'Meara, Manager, Divisional Regulatory Reporting at 201-831-5970.
Root Cause
Process change control
Distribution Pattern
Worldwide Distribution -- US and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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