Z-1608-2009

Offset Adaptor Trial - 4MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325...

Name: Z-1608-2009 Offset Adaptor Trial - 4MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-04-16
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-04-16 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Offset Adaptor Trial - 4MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430. Indications for use... on 2009-04-16. The reason FDA records is "Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1608-2009
Status: Terminated
Initiated: 2009-04-16
Posted: 2009-07-23
Terminated: 2010-04-05
Recalling firm: Howmedica Osteonics Corp
Product: Offset Adaptor Trial - 4MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive, Mahwah, NJ 07430. Indications for use include disabling joint disease of the knee.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: "Urgent Product Correction" letters dated April 16, 2009 were sent to all Stryker Representatives, Hospital Rick Management Departments, Hospital Chief of Orthopaedics, Surgeon and countries by Federal Express. The notice explains the Issue, Potential Hazards and Risk Mitigation Factors of the affected product(s) including a request to complete and return the Product Correction Form. For further questions, contact Stryker Orthopedics, Division of Regulatory Reporting at 201-831-5970.
Quantity in commerce: 2498 total units, all sizes
Distribution: Worldwide Distribution.
Product codes and lots: Catalog number 5570-T-040; All Lot Numbers.

Product code JWH

K070095Class IITriathlon Ts Knee SystemHowmedica Osteonics Corp. / cleared 2007-06-01

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)