—#95230

Product

Smith & Nephew FAST FIX 360, CURVED NEEDLE Catalog Number; 72202468. Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy.

FDA product code: GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K092508
Affected lot / code info: Lot Numbers: 50327270, 50327276, 50327424, 50327429, 50327431, 50327894, 50327900, 50327903, 50327905, and 50327908.

Why it was recalled

FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.

Root cause (FDA determination)

Device Design

Action the firm took

Smith & Nephew notified customers by an Urgent - Product Recall 1st Notification - Urgent letter sent via Federal Express October 14, 2010. The letter identified the affected product and explained the problem. The letter asked customers to call for a Return Authorization (RA) Number. Customers are to complete the form and return of the affected product along with a copy of the letter to the address provided being sure to reference the RA number. Questions were to be directed to Cindy Burns at 508-261-3655. Consignees out side the US were notified by e-mail.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA, Dubai, and Great Britain.

Timeline

Recall initiated: 2010-10-14
Posted by FDA: 2010-11-18
Terminated: 2012-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95230. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.