Recall Z-2812-2011 ยท GAP Suture, Nonabsorbable, Silk
Covidien LP
Syneture Sofsilk 5/0 BLACK 5 X 18" CV-22 D*TACH non-absorbable silk sutures GS43M Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
| Date | Jul 15, 2011 (initiated Jun 3, 2011) |
| Status | Terminated |
| Reason | Potential for the sterile barrier to be breached compromising the sterility of the product |
| Root 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 |
| Quantity | 528 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981128 | SOFSILK SUTURE United States Surgical, A Division of Tyco Healthc, May 11, 1998 |