FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Triathlon Revision Instruments; 1,2,7,8 TGC 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.
- Recall number
- Z-1618-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Triathlon Revision Instruments; 1,2,7,8 TGC 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.
- Status
- Terminated
- Initiated
- 2009-05-15
- Posted
- 2009-07-15
- Terminated
- 2010-04-05
- Reason
- The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.
- Root cause
- Process change control
- 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.
- Quantity
- 27
- Distribution
- Worldwide Distribution -- US and Canada.
- Lot, serial or model codes
- Catalog Numbers: 6543-8-014, 6543-8-015.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28