Recall Z-0798-06 ยท KGS Retention Device, Suture
Smith & Nephew, Inc. Endoscopy Division
FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399
| Date | Apr 26, 2006 (initiated Mar 24, 2006) |
| Status | Terminated |
| Reason | The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment of the T2 anchor. |
| Root cause | Other |
| Action | Smith & Nephew notified accounts by letter dated 3/24/06 issued by Federal Express. Users are requested to return product. |
| Quantity | 1800 units |
| Distribution | Nationwide Foreign: Austria, Germany, France, Italy, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020480 | RBM Smith & Nephew, Inc., Mar 12, 2002 |