GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA Drill guide used as manual surgical instrument during knee replacement surgeries.
FDA Recall Z-1900-2010 · Posted 2010-06-24
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Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-04-20
Date Terminated2011-12-07
Product Quantity12 units
Reason for Recall
Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side
Firm Action
All affected Smith & Nephew consignees (International distributors) were notified of problem and the recall via email on 04/20/2010 and an Urgent: Medical Device Recall letter, dated 4/16/2010. The letter stated the reason for the recall and distributors were requested to immediately cease distribution and use of the affected products. They were also asked to examine their stock and stock of their accounts and quarantine any affected product. The Verification Section of the letter should be completed and returned even if there is no affected stock. Anyone the product was distributed to should also be notified and also return the product. Questions should be directed to Kelly Knight at 901-399-5441.
Root Cause
Process control
Distribution Pattern
International Distribution Only -- Belgium, Spain, Germany, Australia, and Brazil.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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