Z-1095-2011

Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics...

Name: Z-1095-2011 Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2010-12-22
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-12-22 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howmedica Osteonics Corp., 325 Corporate... on 2010-12-22. The reason FDA records is "Stryker Orthopaedics has become aware that the labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should read June 2014...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1095-2011
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-02-11
Terminated: 2012-10-03
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. One single unit to a package. Triathlon Distal Femoral Fixation Pegs are made available separate from the Triathlon Posteriorly Stabilized Femoral Component. These distal femoral fixation pegs are an accessory to the Triathlon Femoral Component and are optional for use. These pegs are designed to provide rotational stability and to aid the surgeon in the placement of the femoral component on the prepared distal femur. The Triathlon Distal Femoral Fixation Pegs are fabricated from wrought cobalt alloy. The distal portion of the fixation peg is thread to allow the peg to be assembled to the distal threaded hole in the Triathlon femoral component. The proximal portion of the peg is recessed to allow the use of a wrench to assemble the peg into the femoral complement.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Stryker Orthopaedics has become aware that the labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should read June 2014 (2014-6).
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: The firm, Stryker, sent a "UPDATED (Corrected Lot Code) URGENT PRODUCT RECALL" letter dated January 6, 2011, via Fed Ex ,with return receipt to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to fax the attached Product Recall Acknowledgement form to (201) 831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product, and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team at (201) 831-5028.
Quantity in commerce: 15 units
Distribution: Nationwide distribution.
Product codes and lots: Lot #SMTFJ

Product code JWH

K031729Class IITriathlon Posteriorly Stabilized (Ps) Total Knee SystemHowmedica Osteonics Corp. / cleared 2003-09-02

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)