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U.S. Department of Health and Human Services

Class 2 Device Recall Syneture Surgilon

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  Class 2 Device Recall Syneture Surgilon see related information
Date Initiated by Firm June 03, 2011
Date Posted July 15, 2011
Recall Status1 Terminated 3 on February 10, 2014
Recall Number Z-2819-2011
Recall Event ID 59104
510(K)Number K981128  
Product Classification Suture, nonabsorbable, silk - Product Code GAP
Product Syneture Sofsilk 0 BLACK 6X 18" PRE-CUT WAX/RACE
non-absorbable braided nylon sutures
S196

Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
Code Information Lot Code Number:  D1C0270
Recalling Firm/
Manufacturer		 Covidien LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact
203-492-5000
Manufacturer Reason
for Recall		 Potential for the sterile barrier to be breached compromising the sterility of the product
FDA Determined
Cause 2		 Equipment maintenance
Action Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product. Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product. Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
Quantity in Commerce 768 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
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 = GAP and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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