Z-0866-2014Class II

SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver...

Name: Z-0866-2014 SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2014-01-03
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2014-01-03 / Terminated

FDA source

Medtronic Sofamor Danek USA Inc began a recall of SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument on 2014-01-03. FDA classified it as Class II and gives the reason as "The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0866-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-03
Posted: 2014-01-30
Terminated: 2014-05-16
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
Product code: HXX Screwdriver
Reason for recall: The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
FDA root cause: Reprocessing Controls
Action: The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included, on 01/03/2014.
Quantity in commerce: 7 units
Distribution: US Distribution in the states of CA, NC, TX, IN, NJ, and MI.
Product codes and lots: TI13J01811

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0866-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0866-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-30

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)