| Date Initiated by Firm | July 12, 2007 |
|---|
| Date Posted | August 14, 2007 |
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| 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. |
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| Quantity in Commerce | 8, 860 units |
|---|
| Distribution | Nationwide |
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| 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.
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| 510(K) Database | 510(K)s with Product Code = GEI
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