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U.S. Department of Health and Human Services

Class 2 Device Recall Bayonet Electrosurgical Pencil

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 Class 2 Recall
Bayonet Electrosurgical Pencil
see related information
Date Posted August 14, 2007
Recall Status1 Terminated on March 07, 2008
Recall Number Z-1150-2007
Recall Event ID 38458
Premarket Notification
510(K) Number
K930511 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils.
Code Information Product Number 9560575-900. Lot numbers 3003-1, 111805, 182275, 182280, 182290, 182300, 182310, 182320, 182330, and 182340.
Recalling Firm/
Manufacturer
Zinnanti Surgical Design LLC
42 Forest Ave
Hershey, Pennsylvania 17033-2018
For Additional Information Contact Jelena Zinnanti
717-649-8124
Manufacturer Reason
for Recall
Bubble Leak Test Failure of sterility barrier, therefore sterility of the device may be compromised
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action The recalling firm issued an Urgent Medical Device Recall Letter dated 7/24/07 to its single wholesaler requesting recall and sub-recall to all their consignees.
Quantity in Commerce 8, 860 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = W. J. MEDICAL INSTRUMENTS, INC.
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