Z-1619-2009

Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile; Howmedica Osteonics Corp., 325 Corporate...

Name: Z-1619-2009 Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile; Howmedica Osteonics Corp., 325 Corporate...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-05-15
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-05-15 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. For total knee arthroplasty... on 2009-05-15. The reason FDA records is "The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1619-2009
Status: Terminated
Initiated: 2009-05-15
Posted: 2009-07-15
Terminated: 2010-04-05
Recalling firm: Howmedica Osteonics Corp
Product: 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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.
FDA 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 in commerce: 26
Distribution: Worldwide Distribution -- US and Canada.
Product codes and lots: Catalog Number: 6543-8-014.

Product code JWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)