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Terminated

Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed by Smith & Nephew.

FDA Recall Z-2314-2009 · Posted 2009-09-24

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeLZY
Date Initiated2009-01-12
Date Terminated2011-03-25
Product Quantity10 units

Reason for Recall

46 mm Femoral head was mismarked and packaged as being 45 mm

Firm Action

All affected Smith & Nephew Sales Representatives were notified of problem and sent recall notice in overnight mail on 01/12/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/12/2009. They were instructed to immediately quarantine the product for return. The firm re-issued the letter on 04/06/2009 to address hazard to health. Contact Smith & Nephew, Inc at 1.901.399.6771 if there are any questions.

Root Cause

Process control

Distribution Pattern

CA, FL, MI, and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030766OXINIUM FEMORAL HEADSSmith & Nephew, Inc. · 2003-07-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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