Recalls / —

—#46831

Product

4.5 mm TRIVEX System Resector Kit (blade and tubing), 3 per box Part Number: 7209514

FDA product code

GEI — Electrosurgical, Cutting & Coagulation & Accessories

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K990723

Affected lot / code info

Lot Numbers: All lot numbers lower than 50165371 Expanded Recall: Lot Numbers: 50172224, 50173178, 50173179, 50174332, 50174790, 50175034, 50175829, 50175830

Why it was recalled

The sterility seal of the package trays may have incomplete seals compromising the sterility of the device

Root cause (FDA determination)

Other

Action the firm took

Smith & Nephew initiated the recall by Certified Letter on June 19, 2006 requesting return of the recalled products. Smith & Nephew expanded the recall to include additional lots. The firm issued the recall expansion letter dated 8/25/06.

Recalling firm

Firm

Smith & Nephew, Inc. Endoscopy Division

Address

150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern

Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK.

Timeline

Recall initiated

2006-06-19

Posted by FDA

2006-07-13

Terminated

2008-01-10

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #46831. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.