Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
FDA Recall Z-1381-2008 · Posted 2008-07-16
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-02-08
Date Terminated2008-07-16
Product Quantity7 units
Reason for Recall
Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.
Firm Action
Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.
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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