FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399
FDA device recall Z-0798-06 · posted 2006-04-26 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Reason for recall
- 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.
- Action taken
- Smith & Nephew notified accounts by letter dated 3/24/06 issued by Federal Express. Users are requested to return product.
- Root cause
- Other
- Status
- Terminated
- Product code
- KGS
- Quantity affected
- 1800 units
- Distribution
- Nationwide Foreign: Austria, Germany, France, Italy, Australia
- Date initiated
- 2006-03-24
- Date posted
- 2006-04-26
- Date terminated
- 2007-12-12
- Location
- Andover, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RBM (K020480) | Smith & Nephew, Inc. | 2002-03-12 |