Z-1150-2007

Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils

Name: Z-1150-2007 Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils
Creator: Zinnanti Surgical Design LLC
Published: 2007-07-12
License: https://open.fda.gov/license/

Zinnanti Surgical Design LLC / initiated 2007-07-12 / Terminated / root cause: sterility

FDA source

Zinnanti Surgical Design LLC began a recall of Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils on 2007-07-12. The reason FDA records is "Bubble Leak Test Failure of sterility barrier, therefore sterility of the device may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1150-2007
Status: Terminated
Initiated: 2007-07-12
Posted: 2007-08-14
Terminated: 2008-03-07
Recalling firm: Zinnanti Surgical Design LLC
Product: Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Bubble Leak Test Failure of sterility barrier, therefore sterility of the device may be compromised
Root cause tag: sterility
FDA root cause: 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
Product codes and lots: Product Number 9560575-900. Lot numbers 3003-1, 111805, 182275, 182280, 182290, 182300, 182310, 182320, 182330, and 182340.

Product code GEI

K930511Class IIStealth Surgical Irrigator AspiratorW. J. Medical Instruments, Inc. / cleared 1993-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)