LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.
FDA Recall Z-1819-2009 · Posted 2009-08-23
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Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-01-22
Date Terminated2012-02-07
Product Quantity16 units
Reason for Recall
Products were mispackaged.
Firm Action
All affected Smith & Nephew Sales Representatives were notified of the problem and the recall via email and overnight mail on January 22, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 22, 2009. They were instructed to immediately quarantine the product for return.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France.
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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