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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 Surgilonsee related information
Date Initiated by FirmJune 03, 2011
Date PostedJuly 15, 2011
Recall Status1 Terminated 3 on February 10, 2014
Recall NumberZ-2818-2011
Recall Event ID 59104
510(K)NumberK981128 
Product Classification Suture, nonabsorbable, silk - Product Code GAP
Product Syneture Sofsilk 3/0 BK 12X18" PRE-CUT WAX-RACE non-absorbable braided nylon sutures S194 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:  D1C0213
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
ActionCovidien 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 Commerce960 units
DistributionWorldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GAP
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