Class 2 Device Recall Smith & Nephew

• Date Initiated by Firm: July 01, 2005
• Date Posted: January 11, 2006
• Recall Status: Terminated on September 27, 2016
• Recall Number: Z-0371-06
• Recall Event ID: 32590
• Product Classification: Orthopedic Manual Surgical Instrument - Product Code LXH
• Product: Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) Reference Number: 7210430
• Code Information: Lot Number: 50102446
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc., Endoscopy Div.; 130 Forbes Blvd; Mansfield MA 02048-1145
• For Additional Information Contact: Cindy Burns; 508-261-3655
• Manufacturer Reason for Recall: Drill does not contain laser etched depth marks to assure proper depth of inserted device
• FDA Determined Cause: Other
• Action: Smith & Nephew notified accounts by Federal Express 07/01/2005 . Accounts are requested tor return units. Sales representatives notified by email.
• Quantity in Commerce: 4 units
• Distribution: NC, PR
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.