—#45171

Product

FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 7209399

FDA product code: KGS — Retention Device, Suture
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K020480
Affected lot / code info: Lot Numbers: 50141993, 50145519, 50146091,50146096, 50146362, 50148283, 50146365, 50153066, 50150381

Why it was recalled

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 (FDA determination)

Other

Action the firm took

Smith & Nephew notified accounts by letter dated 3/24/06 issued by Federal Express. Users are requested to return product.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: Nationwide Foreign: Austria, Germany, France, Italy, Australia

Timeline

Recall initiated: 2006-03-24
Posted by FDA: 2006-04-26
Terminated: 2007-12-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45171. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.