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U.S. Department of Health and Human Services

Class 2 Device Recall Monodek

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  Class 2 Device Recall Monodek see related information
Date Initiated by Firm March 11, 2014
Date Posted April 25, 2014
Recall Status1 Terminated 3 on September 25, 2017
Recall Number Z-1509-2014
Recall Event ID 67972
510(K)Number K030212  
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
Product Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
Code Information Product Code: 833-137, Batch: 02H1103434, 02H1200349, and 02K1201354.
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr.
Research Triangle Park NC 27709
For Additional Information Contact Michael T. Taggart
919-433-4940
Manufacturer Reason
for Recall		 Product does not meet minimum knot tensile strength requirements.
FDA Determined
Cause 2		 Under Investigation by firm
Action Consignees were notified by an Urgent Medical Device Recall Notification letter, dated 3/11/2014. The letter identified the affected product and the reason for recall. Customers were instructed to immediately discontinue use of and quarantine any affected product in stock. The affected product is to be returned; and the Recall Acknowledgement Form should be completed and faxed to the number provided regardless of whether customers have affected product in stock. Questions should be directed to a local sales rep or Customer Service at 1-866-246-6990.
Quantity in Commerce 3,072 ea.
Distribution Worldwide Distribution -- USA, including the state of MA, and the country of 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 = NEW and Original Applicant = GENZYME BIOSURGERY
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