Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Smith & Nephewsee related information
Date Initiated by FirmFebruary 19, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 28, 2006
Recall NumberZ-0704-04
Recall Event ID 28423
Product Classification Camera, Still, Endoscopic - Product Code FXM
ProductEndocoupler, C-Mount 30 mm Focal Length Catalog Number: 7204823, 7204823S
Code Information 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     
FEI Number 3003604053
Recalling Firm/
Manufacturer		 Smith And Nephew, Inc. Endoscopy Division
150 Minuteman Rd
Andover MA 01810-1031
For Additional Information Contact
614-624-3688
Manufacturer Reason
for Recall		Endocouplers assembled with screws that cannot be effectively sterilized
FDA Determined
Cause 2		Other
ActionSmith & 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 in Commerce28 units
DistributionAL, 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-