Recalls / —

—#31812

Product

Endocoupler, C-Mount 30 mm Focal Length Catalog Number: 7204823, 7204823S

FDA product code

FXM — Camera, Still, Endoscopic

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Part No: 7204823 Serial #s: SR 8433  SR 8472  SR 8504  SR 8562  SR 8391  SR 8506  SR 8538  SR 8555  SR 8392  SR 8395  SR 8489  SR 8494  SR 8554  SR 8471  SR 8485  SR 8477  SR 8568  SR 8513  SR 8514  SR 8394  SR 8520  SR 8493  SR 8567  SR 8569  SR 8396  SR 8533  SR 8561  SR 8534  7204823S SR 8623 SR 8422 SR 8563 SR 8590 SR 8577 SR 8591 SR 8628 SR 8495 SR 8576 SR 8627 SR 8426 SR 8490 SR 8499 SR 8587 SR 8573 SR 8428 SR 8574 SR 8578 SR 8580 SR 8589 SR 8565 SR 8566 SR 8498 SR 8564 SR 8620

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 #31812. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.