Device Recall Triathlon

Lot #SMTFJ

Orthopedic Devices

2

Yes

Nationwide distribution.

Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. || One single unit to a package. || Triathlon Distal Femoral Fixation Pegs are made available separate from the Triathlon Posteriorly Stabilized Femoral Component. These distal femoral fixation pegs are an accessory to the Triathlon Femoral Component and are optional for use. These pegs are designed to provide rotational stability and to aid the surgeon in the placement of the femoral component on the prepared distal femur. The Triathlon Distal Femoral Fixation Pegs are fabricated from wrought cobalt alloy. The distal portion of the fixation peg is thread to allow the peg to be assembled to the distal threaded hole in the Triathlon femoral component. The proximal portion of the peg is recessed to allow the use of a wrench to assemble the peg into the femoral complement.

Catalog Number 5650-4-512 Catalog Number 5650-4-536

Orthopedic Devices

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

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.

Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A

Orthopedic Devices

2

Yes

USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA

Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 || The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.

Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A

Orthopedic Devices

2

Yes

Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.

Knee Prosthesis, Sterile, Single-Use devices || Product Usage: || The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function

Ref. No. 5530-G-211 Lot code G9XF6  LAF974

Orthopedic Devices

2

Yes

Nationwide and Canada.

Triathlon X3 CR Tibial Bearing Insert || for knee prosthesis || Size #2 - 11MM || Ref # 5530-G-211 || 2011-09 || Howmedica Osteonics Corp.