Atlas FDA

Endocoupler C-Mount 35 mmFocal Length Catalog Number: 6900398

FDA device recall Z-0705-04 · posted 2004-07-20 · Terminated

Recall details

Recalling firm
Smith And Nephew, Inc. Endoscopy Division
Reason for recall
Endocouplers assembled with screws that cannot be effectively sterilized
Action taken
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
Status
Terminated
Product code
FXM
Quantity affected
2 units
Distribution
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
Date initiated
2004-02-19
Date posted
2004-07-20
Date terminated
2006-06-28
Location
Andover, MA

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