Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils.
FDA device recall Z-1150-2007 · posted 2007-08-14 · Terminated
Recall details
- Recalling firm
- Zinnanti Surgical Design LLC
- Reason for recall
- Bubble Leak Test Failure of sterility barrier, therefore sterility of the device may be compromised
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 8, 860 units
- Distribution
- Nationwide
- Date initiated
- 2007-07-12
- Date posted
- 2007-08-14
- Date terminated
- 2008-03-07
- Location
- Hershey, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEALTH SURGICAL IRRIGATOR ASPIRATOR (K930511) | W. J. Medical Instruments, Inc. | 1993-06-25 |