Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398
FDA Recall Z-0705-04 · Posted 2004-07-20
Recalling FirmSmith And Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeFXM
Date Initiated2004-02-19
Date Terminated2006-06-28
Product Quantity2 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.