Class 3 Device Recall Look Brand Black Monofilament Nylon Suture

• Date Initiated by Firm: September 24, 2005
• Date Posted: October 21, 2005
• Recall Status: Terminated on December 14, 2005
• Recall Number: Z-0085-06
• Recall Event ID: 33771
• Product Classification: Suture, Nonabsorbable, Synthetic, Polyamide - Product Code GAR
• Product: Look Brand Black Monofilament Nylon Suture. 2xS Taper Straight 61 mm 2/0 Black Monofilament Nylon 30''. Model number 933B. The product is shipped in boxes containing 12 units.
• Code Information: Lot number M732780
• Recalling Firm/ Manufacturer: Surgical Specialties Corp; 100 Dennis Dr; Reading PA 19606-3776
• For Additional Information Contact: Dianna Shurr; 610-404-1000 Ext. 2229
• Manufacturer Reason for Recall: mislabeled as double armed straight needle actually single armed straight needle
• FDA Determined Cause: Other
• Action: On 9/24/05, the recalling firm issued notifications to their customers via fax informing them of the problem and the need to return any remaining product to the recalling firm.
• Quantity in Commerce: 27 boxes
• Distribution: The product was shipped to hospitals in IL, KY, NC, NE, OR, UT, and VA. The product was also shipped to distributors in FL, KY, PA, TN, and VA.
• 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.