Z-0114-2008

Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw...

Name: Z-0114-2008 Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw...
Creator: Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Published: 2007-09-04
License: https://open.fda.gov/license/

Warsaw Orthopedic, Inc. / initiated 2007-09-04 / Terminated / root cause: packaging

FDA source

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK began a recall of Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575 on 2007-09-04. The reason FDA records is "Packaging weakness may compromise sterility and instructions for use are inadequate". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0114-2008
Status: Terminated
Initiated: 2007-09-04
Posted: 2007-11-07
Terminated: 2009-07-14
Recalling firm: Warsaw Orthopedic, Inc.
Product: Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Packaging weakness may compromise sterility and instructions for use are inadequate.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Consignees were notified via letter dated September 4, 2007 to cease using the product and to contact the firm for instructions on how to return the product.
Quantity in commerce: 22,632
Distribution: Worldwide, including USA, Hong Kong, India, Mexico, Netherlands, Qatar, Saudi Arabia and South Korea.
Product codes and lots: All lots.

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)