Class 3 Device Recall 30 Black Mono Nylon Suture

• Date Initiated by Firm: September 09, 2008
• Date Posted: October 02, 2008
• Recall Status: Terminated on March 27, 2009
• Recall Number: Z-0034-2009
• Recall Event ID: 49494
• 510(K)Number: K930825
• Product Classification: Suture - Product Code GAR
• Product: 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
• Code Information: Lot number M335870
• Recalling Firm/ Manufacturer: Surgical Specialties Corp; 100 Dennis Dr; Reading PA 19606
• For Additional Information Contact: Dave Alexander; 610-404-1000
• Manufacturer Reason for Recall: mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture
• FDA Determined Cause: Employee error
• Action: The recalling firm issued a Recall letter dated 9/9/08 to its customers. The letter informed the customers of the problem, the need to conduct a sub-recall, and return the product. Contact Surgical Specialties Corp. at 1-610-404-1000 for assistance.
• Quantity in Commerce: 956 boxes
• Distribution: USA--AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MD, MI, MS, NC, NJ, NY, OH, TN, TX, VA, and WA. OUS: Australia, Canada, and Fiji Islands.
• 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.

• 510(K) Database: 510(K)s with Product Code = GAR and Original Applicant = SURGICAL SPECIALTIES, INC.