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Terminated

Endocoupler , C-Mount 35 mm Focal Length Catalog Number: 7204614, 7204614M, 7204614S

FDA Recall Z-0707-04 · Posted 2004-07-20

Recalling FirmSmith And Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeFXM
Date Initiated2004-02-19
Date Terminated2006-06-28
Product Quantity102 units

Reason for Recall

Endocouplers assembled with screws that cannot be effectively sterilized

Firm Action

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.

Root Cause

Other

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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