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 3 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 3 Device Recall Smith & Nephewsee related information
Date Initiated by FirmApril 06, 2005
Date PostedJuly 07, 2005
Recall Status1 Terminated 3 on June 07, 2006
Recall NumberZ-0973-05
Recall Event ID 32160
Product Classification Clamp, Surgical, General & Plastic Surgery - Product Code GDJ
ProductSmith & Nephew Grasper, Cupped 3.4mm REF: 011014
Code Information Lot Number: 50088937
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc., Endoscopy Div.
130 Forbes Blvd
Mansfield MA 02048-1145
For Additional Information ContactJason Bilobram
978-474-6332
Manufacturer Reason
for Recall		Cupped Grasper Handle marked incorrectly as Duckbill Upbiter
FDA Determined
Cause 2		Other
ActionSmith & Nephew Endoscopy notified users by letter dated 4/6/05. Accounts are requested to return product.
Quantity in Commerce12
DistributionCA, OH, MA, TX
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.
-
-