||March 18, 2013
||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: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right).
Lot Codes: AP5W52 and AP7H19.
|Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
|For Additional Information Contact
||Ms. Colleen O'Meara
|The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
||A Notification Letter/Product Accountability Form dated 01/28/2013 was sent via FedEx on 01/28/2013 to the sole US branch receiving the affected devices. The branch was instructed to also contact the hospitals in its territory that have the affected product to arrange return of the product. Affected products to be returned to Stryker Orthopaedics, 325 Corporate Drive, Mahway, NJ 07430.
|Quantity in Commerce
||4 units (total of 2 sets)
||1 Branch (NJ) with one consignee (DE).