Class 2 Device Recall Triathlon PKR Peg Drill

• Date Initiated by Firm: February 09, 2011
• Date Posted: March 28, 2011
• Recall Status: Terminated on November 18, 2013
• Recall Number: Z-1835-2011
• Recall Event ID: 57857
• 510(K)Number: K090596
• Product: 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 peg drill, drill guide, and drill through femoral trial are provided. The femoral Trial Drill Guide is attached to the Modular Handle and assembled into the holes on the articulation surface of the Femoral Trial. Using the appropriately sized Peg Drill (Small Drill for sizes 1-2, Large Drill for sizes 3-6), both holes are drilled. The Peg drill is advanced until the step on the drill makes contact with the front face of the Femoral Trial Drill Guide.
• Code Information: Catalog Number 5650-4-512 Catalog Number 5650-4-536
• FEI Number: 3003070421
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 07430
• For Additional Information Contact: Ms. Colleen O'Meara; 201-972-2100
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 in Commerce: 5650-4-512- 754 units; 5650-4-536- 880 units
• Distribution: Worldwide Distribution - USA , Sweden, Germany; France, Portugal, UK, Canada, Australia, and New Zealand,

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code =