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Terminated

CERCLAGE WIRE, 0.8 MM DIA. X 200 MM LENGTH, SST, REF 71163008, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Germany Usage: Bone fracture fixation

FDA Recall Z-2198-2010 · Posted 2010-08-10

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeJDQ
Date Initiated2010-06-28
Date Terminated2012-01-23
Product Quantity34 units

Reason for Recall

Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.

Firm Action

All affected Smith & Nephew Sales Representatives were notified of problem and the recall was sent via overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return.

Root Cause

Process control

Distribution Pattern

KY, TX, DC, NC, CA, AZ, GA and OH; 3 International: Australia, Malaysia, and Switzerland

Official Source

View FDA Recall →

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

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