Z-0952-2015Class II

POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal...

Name: Z-0952-2015 POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2014-12-03
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2014-12-03 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent on 2014-12-03. 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, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0952-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-03
Posted: 2015-01-12
Terminated: 2015-09-24
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Medtronic sent an Urgent - Voluntary Market Removal letter dated December 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions to Customers: 1.) Please remove the product from normal storage locations. Do not use this product. 2.) As applicable, contact your Medtronic Sales Representative to coordinate the return of affected product. Alternatively, you may call Medtronic's Global Quality Department at (800) 876 -3133, extension 3197 for assistance If you need assistance or have any related questions or concerns, please do not hesitate to contact your Medtronic Sales Representative or the Global Quality Department at (800) 876 - 3133, extension 3197. We sincerely apologize for this inconvenience, but this action is necessary to assure that our high standard of quality is maintained.
Quantity in commerce: 24 units
Distribution: US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.
Product codes and lots: Lot # - CA14C107

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0952-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0952-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-12

Product code HWE

K111520Class IIIpc Powerease SystemMedtronic Xomed, Inc. / cleared 2011-10-26

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)