Z-1579-2008

Triathlon TS Femoral Trial; Size 4 Right Non-Sterile Catalog Number: 5512-T-402 Howmedica Osteonics Corp. 325...

Name: Z-1579-2008 Triathlon TS Femoral Trial; Size 4 Right Non-Sterile Catalog Number: 5512-T-402 Howmedica Osteonics Corp. 325...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-03-05
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-03-05 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Triathlon TS Femoral Trial; Size 4 Right Non-Sterile Catalog Number: 5512-T-402 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic... on 2008-03-05. The reason FDA records is "Sharp edges will cause a glove to tear and cut someone. Sharp edges on the slots machines in select lots of the Triathlon TS Femoral Trials, sizes 1-8, have been discovered". 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-1579-2008
Status: Terminated
Initiated: 2008-03-05
Posted: 2008-07-26
Terminated: 2010-10-25
Recalling firm: Howmedica Osteonics Corp
Product: Triathlon TS Femoral Trial; Size 4 Right Non-Sterile Catalog Number: 5512-T-402 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Sharp edges will cause a glove to tear and cut someone. Sharp edges on the slots machines in select lots of the Triathlon TS Femoral Trials, sizes 1-8, have been discovered.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker Branches/Agencies were notifed by letter (Urgent Product Recall) on March 5, 2008. Reps were asked to examine inventory and visit hospitals that were provided with the device to retrieve product. Reps were instructed to retrieve all of the affected product lots and return them to their branch or agency warehouse for reconciliation. All products should be reconcilied on the Product Accountability Form that is attached to the letter and sent via Inter-Org Transfer back to Stryker Orthopaedics. Questions and re-orders of the product that is being returned should be directed to 201-831-5825.
Quantity in commerce: 12
Distribution: Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ.
Product codes and lots: Lot codes:N4XMPD,WFDC,

Product code LXH

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)