Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Sterile. Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corp. Made in Ireland. The Triathlon Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
FDA Recall Z-0579-2009 · Posted 2009-01-08
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMBH
Date Initiated2006-09-21
Date Terminated2009-01-09
Product Quantity10
Reason for Recall
Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.
Firm Action
Important Market Withdrawal notification letters were sent via Fed Ex on 9/20/06 to the direct accounts. Notification letters informed of the reason for the market withdrawal and requested that all branches examine their inventory and hospital consignment locations to identify the product. Product was to be reconciled on the Product Accountability Form and returned to Stryker as per instructions. Contact Stryker Howmedica Osteonics Corp at 1-201-831-5718 for assistance.
Root Cause
Process change control
Distribution Pattern
PA, GA, AL, WI, UT, and OR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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