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U.S. Department of Health and Human Services

Class 2 Device Recall Bondek Absorbable Sutures

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  Class 2 Device Recall Bondek Absorbable Sutures see related information
Date Initiated by Firm February 01, 2010
Date Posted August 26, 2010
Recall Status1 Terminated 3 on April 19, 2011
Recall Number Z-2287-2010
Recall Event ID 54474
510(K)Number K991191  
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
Product Deknatel Bondek¿ Plus Polyglycolic Absorbable Surgical Sutures, Bon+VI R 0 HRX27 1N (70 cm), Teleflex Medical.
Code Information Catalog Number: EP1081P, Lot number: 02A0801448, 02A0802800, 020A802802 and 02A0801433.
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 2		 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 and Original Applicant = GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
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