Class 2 Device Recall Syneture Sofsilk

• Date Initiated by Firm: June 03, 2011
• Date Posted: July 15, 2011
• Recall Status: Terminated on February 10, 2014
• Recall Number: Z-2813-2011
• Recall Event ID: 59104
• 510(K)Number: K981128
• Product Classification: Suture, nonabsorbable, silk - Product Code GAP
• Product: Syneture Sofsilk 4/0 18" BLACK CV-22 DT non-absorbable silk sutures GS44M 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: D1C0026 D1C0028
• 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: 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: 3600 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