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.
Recall
- Recall Number
- Z-1095-2011
- Event Number
- 57660
- Firm
- Stryker Howmedica Osteonics Corp.
- FEI Number
- 3003070421
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Incorrect or no expiration date
- Initiated
- December 22, 2010
- Posted
- February 11, 2011
- Terminated
- October 3, 2012
- Address
- 325 Corporate Drive, Mahwah, NJ, 07430
Description
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.
Stryker Orthopaedics has become aware that the labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should read June 2014 (2014-6).
The firm, Stryker, sent a "UPDATED (Corrected Lot Code) URGENT PRODUCT RECALL" letter dated January 6, 2011, via Fed Ex ,with return receipt to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to fax the attached Product Recall Acknowledgement form to (201) 831-6069; contact the hospitals in their territory that have the affected product to arrange return of the product, and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100 or the Associate Product Manager, Knee Marketing Team at (201) 831-5028.
Nationwide distribution.
15 units