Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.
FDA Recall Z-1814-2008 · Posted 2008-09-11
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeKWY
Date Initiated2005-11-08
Date Terminated2010-05-13
Product Quantity8 units
Reason for Recall
Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.
Firm Action
Consignees were notified by letter sent via Federal Express with return receipt on November 8, 2005. All consginees who received the subject devices were provided Product Accountability forms to be returned to the firm.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution
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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