Recall Z-1578-2008 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Triathlon TS Femoral Trial; Size 4 Left Non-Sterile Catalog Number: 5512-T-401 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.
| Date | Jul 26, 2008 (initiated Mar 5, 2008) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 19 |
| Distribution | Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.