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U.S. Department of Health and Human Services

Class 3 Device Recall SCANLAN Premier Jacobson Micro Scissors

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 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-1532-05
Recall Event ID 32790
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
ProductScanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled micro fine blades, 6-1/4'', 16 cm. Catalog Number 7007-449.
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.
FEI Number 2126670
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 Commerce34
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.
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