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Terminated

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.

FDA Recall Z-2334-2010 · Posted 2010-08-31

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-09-01
Date Terminated2012-08-27
Product QuantityLot Code: SH7RP - 6 in the US. Lot Code SH8NT was not received in the US.

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.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Nationwide distribution: AL, AZ, CA, MT, NJ and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040267TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEEHowmedica Osteonics Corp. · 2004-05-05K031729TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEMHowmedica Osteonics Corp. · 2003-09-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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