Recall Z-1822-2015 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Smith & Nephew, Inc.
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
| Date | Jun 22, 2015 (initiated Apr 30, 2015) |
| Status | Terminated |
| Reason | Sterility of device maybe compromised |
| Root cause | Package design/selection |
| Action | Smith & Nephew sent an Urgent - Product Recall 1st Notification letter dated April 27, 2015, via Federal Express on April 30, 2015. Users are requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the the Inventory Return Certification and obtain a RGA and obtain replacement product. Contact Smith & Nephews Field Action Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number |
| Quantity | 202,279 units |
| Distribution | Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132079 | TFCC FAST-FIX KIT Smith & Nephew, Inc., Dec 5, 2013 |