Stryker Howmedica Osteonics Corp.
Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: 5650-4-536 (Size 3-6 Peg Drill); Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The Triathlon-PKR Knee System is indicated for primary partial knee resurfacing (PKR). This system utilizes two fixation pegs on the femoral component for fixation and alignment. To prepare for these features, a p
| Date | Mar 28, 2011 (initiated Feb 9, 2011) |
| Status | Terminated |
| Reason | Stryker Orthopaedics has identified a trend of complaints involving reports of the peg drill cold welding to the drill guide, causing the Peg Drill to cease functioning. If cold welding of these components occurs, the following potential patient and/or surgeon or surgical staff harms may results. |
| Root cause | Component change control |
| Action | Stryker sent Urgent Product Recall letters on February 9, 2011, and February 10, 2011, via Fed Ex. to all affected customers. The letters identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete and fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069. For questions regarding this recall call 201-972-2100. |
| Quantity | 5650-4-512- 754 units; 5650-4-536- 880 units |
| Distribution | Worldwide Distribution - USA , Sweden, Germany; France, Portugal, UK, Canada, Australia, and New Zealand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090596 | ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM Zimmer, Inc., Jun 30, 2009 |