—#69428

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.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot codes:N4XMPD,WFDC,

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ.

Timeline

Recall initiated: 2008-03-05
Posted by FDA: 2008-07-26
Terminated: 2010-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69428. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.