Recall Z-0707-04 ยท FXM Camera, Still, Endoscopic
Smith And Nephew, Inc. Endoscopy Division
Endocoupler , C-Mount 35 mm Focal Length Catalog Number: 7204614, 7204614M, 7204614S
| Date | Jul 20, 2004 (initiated Feb 19, 2004) |
| Status | Terminated |
| Reason | Endocouplers assembled with screws that cannot be effectively sterilized |
| Root cause | Other |
| 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. |
| Quantity | 102 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, South Africa, Spain, Turkey, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.