Class 2 Device Recall Bondek Absorbable Sutures

• Date Initiated by Firm: February 01, 2010
• Date Posted: August 26, 2010
• Recall Status: Terminated on April 19, 2011
• Recall Number: Z-2286-2010
• Recall Event ID: 54474
• 510(K)Number: K905482
• Product Classification: Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
• Product: Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable Surgical Sutures intended uses are in general surgical procedures where general soft tissue approximation and/or ligation are performed, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
• Code Information: Catalog Number: EP4084N, Lot number: 02A0801449
• Recalling Firm/ Manufacturer: Telefelx Medical; 2917 Weck Drive; Durham NC 27709
• For Additional Information Contact: Angela Brown; 919-433-4816
• Manufacturer Reason for Recall: Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box.
• FDA Determined Cause: Labeling mix-ups
• Action: Teleflex Medical issued consignees a "Urgent Medical Device Recall" letter dated February 1, 2010. Distributors were instructed to forward the letter to their consignees to retrieve relevant product from those locations. The letter described the packaging issue and potential impact. Customers were instructed to immediately discontinue use and quarantine any identified products, complete and fax the Recall Acknowledgement Form to 866-804-9881, in order to receive a Return Goods Authorization (RGA) Number, and then return the product to Teleflex Medical for replacement. Affected products received by Teleflex Medical will be destroyed upon receipt.
• Quantity in Commerce: 17 sales units (24 packs per sales unit/408 units)
• Distribution: Worldwide Distribution: USA and Germany
• 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 = GAM