Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mah
FDA device recall Z-1618-2009 · posted 2009-07-15 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.
- Action taken
- 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
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 27
- Distribution
- Worldwide Distribution -- US and Canada.
- Date initiated
- 2009-05-15
- Date posted
- 2009-07-15
- Date terminated
- 2010-04-05
- Location
- Mahwah, NJ
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