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U.S. Department of Health and Human Services

Class 2 Device Recall SS wire suture

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  Class 2 Device Recall SS wire suture see related information
Date Initiated by Firm June 06, 2007
Date Posted July 17, 2007
Recall Status1 Terminated 3 on March 14, 2008
Recall Number Z-1015-2007
Recall Event ID 38220
510(K)Number K930740  
Product Classification Suture - Product Code GAM
Product Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8,SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7, SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2, SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6, SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4,SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B, SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235, SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399.
Code Information SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, Lot #105821; SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8, Lot #80513;  SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7, Lot #1015798;  SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2, Lot #67227;  SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6 SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4, Lot #67228;  SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B, Lot #39238;  SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235, Lot #8727; SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399. Lot #72507. 
Recalling Firm/
Manufacturer		 Teleflex Creek Dr
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Michael Crader
919-433-4829
Manufacturer Reason
for Recall		 Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
Quantity in Commerce 1920 units total for all types of sutures
Distribution Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France 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 = DEKNATEL, INC.
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