Class 2 Device Recall Triathlon Tibial Baseplate

• Date Initiated by Firm: September 01, 2009
• Date Posted: August 31, 2010
• Recall Status: Terminated on August 27, 2012
• Recall Number: Z-2334-2010
• Recall Event ID: 53427
• 510(K)Number: K031729 K040267
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Triathlon Total Knee System Primary Tibial Baseplate; ; Sterile, Made in Ireland.; Howmedica Osteonics; 325 Corporate Drive; Mahwah, NJ 07430; ; The Triathlon system is comprised of a femoral component, tibial tray, and tibial insert that are intended to be used in total knee arthroplasty (if replacement of the articular surf ace of the patella is required, the Duracon patellar components are compatible with the Triathlon components). The Triathlon PS Total Knee System is intended to be used in situation where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon CR Total Knee System consists of a femoral component, tibial insert, and all-polyethylene patellar components that are intended to be used with the previously cleared Triathlon Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon All Polyethylene patellare components are intended to be used with the femoral components of the previously released Duracon Total Knee System, as well as the previously release Triathlon PS Femoral component in situation where replacement of the articular surface of the patella is required. The Triathlon CR Total Knee system is intended to accommodate the posterior cruciate ligament (PCL) if it is present.
• Code Information: # 4 - Catalog Number: 5520-B-400, Lot code: SH8NT; # 2 - Catalog Number: 5520-B-200, Lot Code SH7RP.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 07430
• For Additional Information Contact: Collean O'Meara; 201-972-2100
• Manufacturer Reason for Recall: A lot for lot mix up occurred between the Triathlon Total Knee System Primary Tibial Baseplate # 4 Cemented, Catalog # 5520-B-400, Lot SH8NT and the #2 Cemented, Catalog # 5520-B-200, Lot SH7RP.
• FDA Determined Cause: Mixed-up of materials/components
• Action: The firm, Stryker Orthopaedics, sent an "URGENT PRODUCT RECALL" letter dated September 1, 2009, via FedEx to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to examine their inventory and hospital locations to identify the affected product; retrieve and return all affected products via Inter-Org Transfer and ship to Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430; Attn: Regulatory Reporting, and attach the fluorescent orange PRODUCT REMEDIATION sticker and mark the outer box with the words "PRODUCT RECALL; complete and fax the attached Product Accountability Form and spreadsheet to (201) 831-6069 within 5 days of receipt of the notice. If you have any questions, please contact the Manager, Divisional Regulatory Reporting at (201) 831-5970.
• Quantity in Commerce: Lot Code: SH7RP - 6 in the US. Lot Code SH8NT was not received in the US.
• Distribution: Nationwide distribution: AL, AZ, CA, MT, NJ and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP; 510(K)s with Product Code = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP.