Class 3 Device Recall Sharpoint Hydrodissection Cannula

• Date Initiated by Firm: November 05, 2002
• Date Posted: February 05, 2003
• Recall Status: Terminated on July 31, 2003
• Recall Number: Z-0544-03
• Recall Event ID: 25254
• Product Classification: Cannula, Surgical, General & Plastic Surgery - Product Code GEA
• Product: 25 Gauge Hydrodissection Cannula 1'' (25 mm) with U-Shaped Flattened End
• Code Information: Model Number of Device: 3425 Catalog Number: 3425 Lot number: MK10190 exp 11/2006
• Recalling Firm/ Manufacturer: Surgical Specialties Corp; 100 Dennis Drive; Reading PA 19606-3776
• For Additional Information Contact: Judith A. Bradley; 800-523-3332 Ext. 2218
• Manufacturer Reason for Recall: The wrong product in the box.
• FDA Determined Cause: Other
• Action: The domestic account was contacted via fax on 11/8/02 and 12/10/02. The foreign accounts were contacted via email on 11/5-12/02.
• Quantity in Commerce: 211 units
• Distribution: The product was sent to wholesalers in CA, Spain and Australia
• 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.