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U.S. Department of Health and Human Services

Class 2 Device Recall Monodek Sutures

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  Class 2 Device Recall Monodek 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-1016-2007
Recall Event ID 38220
510(K)Number K030212  
Product Classification Suture - Product Code GAM
Product Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V
Code Information NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Lot #2503061, 2503063, 2761528, 2761529 2694983, 3152877, 3169994, 2395967, 3163970 & 3232258; Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V, Lot #2360982 & 2381287. 
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 BIOSURGERY
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