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-0707-04
Recall Event ID 28423
Product Classification Camera, Still, Endoscopic - Product Code FXM
ProductEndocoupler , C-Mount 35 mm Focal Length Catalog Number: 7204614, 7204614M, 7204614S
Code Information Part No: 7204614  Serial #s: QW 17251   QW 17264 QW 17064  QW 17301 QW 17240  QW 17312 QW 17271  QW 17311 QW 17236  QW 17274 QW 17256  QW 17266 QW 16939  QW 17296 QW 17187  QW 17306 QW 17062  QW 17235 QW 17063  QW 17304 QW 17245  QW 17309 QW 17299  QW 17182 QW 17061  QW 17241 QW 17065  QW 17246 QW 17316  QW 17250 QW 16979  QW 17294 QW 16984  QW 17269 QW 17058  QW 17276 QW 17186  QW 17281 QW 17279  QW 17286 QW 17307  QW 17290 QW 16945  QW 17291 QW 17314  QW 17317 QW 17255  QW 17320 QW 16946  QW 16944 QW 16949  QW 16960 QW 17059  QW 16963 QW 17060  QW 17057 QW 17066  Part No: 7204614M  Serial #s: QW 14735 QW 5709 QW 7623 QW 14560 QW 2701 QW 13306 QW 10665 QW 15180 QW 15114 QW 16358 QW 6058 QW 7968 QW 10807  Part No: 7204614S Serial #s: QW 12364  QW 15063  QW 18182  QW 17009  QW 18017  QW 18011  QW 6103  QW 14098  QW 18016  QW 17037  QW 11192  QW 18183  QW 17007  QW 16545  QW 14024  QW 16291  QW 9983  QW 17035  QW 12988  QW 17031  QW 18180  QW 15194  QW 11626  QW 17000  QW 15987  QW 16068  QW 16360  QW 18004   QW 15852 QW 16111 QW 16581 QW 11689 QW 15148 QW 18173 QW 13125 QW 17033 QW 15878 QW 15895 QW 17039 QW 18005 QW 17036 QW 10883 QW 10101 QW 14937 QW 12600 QW 18195 QW 17014 QW 12172 QW 13286 QW 14804 QW 15494 QW 16591 QW 18197  QW 12065 QW 17038 QW 11699 QW 15091 QW 13797 QW 15941 QW 18009 QW 6327 QW 12382 QW 16160 QW 13645 QW 14801 QW 16723 QW 17011 QW 18014 QW 15446 QW 17016 QW 13867 QW 13994 QW 9574 QW 15607 QW 15352 QW 16296 QW 13203 QW 14232 QW 11717 QW 14071 QW 15111 QW 18027          
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 Commerce102 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.
-
-