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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon Tibial Baseplate

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 Class 2 Recall
Triathlon Tibial Baseplate
see related information
Date Posted August 31, 2010
Recall Status1 Terminated on August 27, 2012
Recall Number Z-2334-2010
Recall Event ID 53427
Premarket Notification
510(K) Numbers
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, New Jersey 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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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.
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