||July 26, 2008
||Terminated on October 25, 2010
|Recall Event ID
Orthopedic Manual Surgical Instrument -
||Triathlon TS Femoral Trial;
Size 3 Left
Catalog Number: 5512-T-301
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
||Code Numbers N4TMPD, PDAMPD, WEWC
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
|For Additional Information Contact
|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.
||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
||Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.