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 SCANLAN Premier Jacobson Micro Scissors

  • 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 SCANLAN Premier Jacobson Micro Scissorssee related information
Date Initiated by FirmJuly 27, 2005
Date PostedSeptember 13, 2005
Recall Status1 Terminated 3 on December 31, 2006
Recall NumberZ-1538-05
Recall Event ID 32790
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
ProductSCANLAN Premier Jacobson Micro Scissors, spring style, round handle, V-neck, 125-degree angled nano blades, 6-1/2'', 16.5 cm. Catalog no. 7007-598.
Code Information Lot numbers: U7A, U7B, U7C, U7D, V7A, V7B, V7C, V7D, and W7A. The lot numbers are located on the inside shank of the instrument near the fulcrum. Please note: If there is a ''T'' on the inside shank of one of the spring handles, the instrument is not included in this recall.
Recalling Firm/
Manufacturer		 Scanlan International Inc
One Scanlan Plaza
Saint Paul MN 55107
For Additional Information ContactJulie Reilly
651-298-0997
Manufacturer Reason
for Recall		Some scissors purchased before May 1, 2005 may not perform properly. They may have a crack in the blade that could break.
FDA Determined
Cause 2		Other
ActionUrgent Medical Device Recall letters were sent 07/27/05 to distributors asking them to retrieve affected product from their customers and return it to Scanlan International, Inc., St. Paul, MN. Distributors are asked to complete and return a Return Fax Form by August 4, 2005 to acknowledge receipt of letter.
Quantity in Commerce41
Distributionworldwide. Including the United States and countries such as: Austria, Canada, China, Denmark, Finland, Germany, Greece, India, Italy, Japan, Korea, Malaysia, The Netherlands, Switzerland and Taiwan.
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.
-
-