Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. Intended to be used with cemented or cementless components in primary or revision total knee arthroplasty.
FDA Recall Z-0911-2010 · Posted 2010-03-02
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2006-02-17
Date Terminated2010-03-03
Product Quantity594 units total - all products.
Reason for Recall
Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts.
Firm Action
Stryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm.
For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution -- United States and Canada.
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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