Recalls / —

—#31839

Product

Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398

FDA product code

FXM — Camera, Still, Endoscopic

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Serial #s: 50001621-2  50001621-1

Why it was recalled

Endocouplers assembled with screws that cannot be effectively sterilized

Root cause (FDA determination)

Other

Action the firm took

Smith & Nephew notified customers and sales rep. by letter dated 2/19/04. Sales reps will retrieve product and replace effected units in the field.

Recalling firm

Firm

Smith And Nephew, Inc. Endoscopy Division

Address

150 Minuteman Rd, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern

AL, AZ, CA, CT, PA, MA, ME, MI, MO, NC, NH, NJ, NY, OH, UT , TN, TX, VT, WA Foreiing:Australia, Canada, China, Brazil, France, Germany, Greece, India, Italy, Japan.Korea, Netherlands, Norway, Portugal, South Africa, Spain, Turkey, UK

Timeline

Recall initiated

2004-02-19

Posted by FDA

2004-07-20

Terminated

2006-06-28

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #31839. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.