Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-1835-2011 · Posted 2011-03-28

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Date Initiated2011-02-09
Date Terminated2013-11-18
Product Quantity5650-4-512- 754 units; 5650-4-536- 880 units

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.

Firm 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.

Root Cause

Component change control

Distribution Pattern

Worldwide Distribution - USA , Sweden, Germany; France, Portugal, UK, Canada, Australia, and New Zealand,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090596ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMZimmer, Inc. · 2009-06-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑