Z-1835-2011

Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: 5650-4-536 (Size...

Name: Z-1835-2011 Triathlon PKR Peg Drill, Catalog Number: 5650-4-512 (Size 1-2 Peg Drill); Catalog Number: 5650-4-536 (Size...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2011-02-09
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2011-02-09 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 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... on 2011-02-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1835-2011
Status: Terminated
Initiated: 2011-02-09
Posted: 2011-03-28
Terminated: 2013-11-18
Recalling firm: Howmedica Osteonics Corp
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.
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.
Root cause tag: manufacturing process
FDA 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 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,
Product codes and lots: Catalog Number 5650-4-512 Catalog Number 5650-4-536

K090596Class IIZimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and Greater Trochanter Antegrade FemZimmer, Inc. / cleared 2009-06-30

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)