Date Initiated by Firm |
July 12, 2007 |
Date Posted |
August 14, 2007 |
Recall Status1 |
Terminated 3 on March 07, 2008 |
Recall Number |
Z-1150-2007 |
Recall Event ID |
38458 |
510(K)Number |
K930511
|
Product Classification |
Bayonet Electrosurgical Pencil - 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 PA 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 |
Other |
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 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.
|
510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = W. J. MEDICAL INSTRUMENTS, INC.
|