Recalls / —

—#31844

Product

Endocpir, Zoom for Dyonics 3-Chip Camera Catalog Number: 7205461

FDA product code

FXM — Camera, Still, Endoscopic

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Part No: 7205461  Serial #s: UE 1130  UE 1234  UE 1142  UE 1127  UE 1143  UE 1212  UE 1216  UE 1222  UE 1226  UE 1217  UE 1145  UE 1227

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 #31844. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.