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U.S. Department of Health and Human Services

Class 2 Device Recall Bondek Sutures

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  Class 2 Device Recall Bondek Sutures 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-1012-2007
Recall Event ID 38220
510(K)Number K992088  
Product Classification Suture - Product Code GAM
Product Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
Code Information Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Lot numbers: 3244075;  Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Lot #2361002; Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Lot #2401863 & 2498856;  Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136, Lot #2443985 & 3080258;  Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Lot #2528539, & 3163971;  Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G, Lot #2554480.
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		 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 = GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
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