Z-0448-2008

Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509...

Name: Z-0448-2008 Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2006-09-19
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-09-19 / Terminated / root cause: design

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Stryker Orthopaedics, Mahwah, New Jersey on 2006-09-19. The reason FDA records is "Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0448-2008
Status: Terminated
Initiated: 2006-09-19
Posted: 2007-12-11
Terminated: 2008-01-18
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Stryker Orthopaedics, Mahwah, New Jersey
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly.
Root cause tag: design
FDA root cause: Device Design
Action: Important Product Correction letters and Product Accountability Forms were sent via Federal Express on 9/19/06 with return receipt. Foreign locations were notified by a Advisory Notice. Notification letters requested that all inventory of the affected items be examined to verify that it assemble correctly. Any product that does not assemble correctly was to be returned to Stryker, Mahwah, NJ. The Product Accountability form was to be completed by each location to notify Stryker that the letter ahd been received and inventory examined. Stryker representatives were to be contacted for product replacement.
Quantity in commerce: 2,868 units total for Recalls Z-0448-0450-2008
Distribution: Worldwide: USA including states of MI and IL. and countries of Australia, China, New Zealand, Singapore, France, Germany, Italy, Portugal, Spain, Sweden and UK.
Product codes and lots: Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right; All lot codes

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)