Device Recall Triathlon

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.

Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right).   Lot Codes: AP5W52 and AP7H19.

Orthopedic Devices

1

No

1 Branch (NJ) with one consignee (DE).

Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE

Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG

Orthopedic Devices

2

Yes

Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.

Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package || Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA || Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 || Meyzieu, Cedex, France || This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone