Z-2823-2015Class II

P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N...

Name: Z-2823-2015 P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N...
Creator: Medtronic Navigation, Inc.
Published: 2015-09-14
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2015-09-14 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Navigation, Inc. began a recall of P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N... on 2015-09-14. FDA classified it as Class II and gives the reason as "Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2823-2015
Classification: Class II
Status: Terminated
Initiated: 2015-09-14
Posted: 2015-09-30
Terminated: 2015-12-03
Recalling firm: Medtronic Navigation, Inc
Product: P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN; P/N: 9735027,DRIVER 9735027 SOLERA 5.5/6.0 FAS/SAS. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Medtronic sent an Urgent Medical Device Correction Notification letter dated September 14, 2015, to all affected consignees via FedEx. Revised Instructions for Use were provided to add additional warnings related to the careful inspection of the instruments and the importance of knowledge of operating procedures, patient selection, and product information. Consignees with questions were instructed to to call the local Medtronic Navigation Technical Services Representative or call 1-800-995-9709.
Quantity in commerce: 2,346
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Canada; United Arab Emirates; Australia; Belgium; Switzerland; China; Germany; Denmark; Spain; Finland; France; Great Britain; Greece; India; Israel; Italy; Japan; Netherlands; New Zealand; Poland; Portugal; Sweden; Singapore; Thailand; Slovakia; Turkey; and South Africa.
Product codes and lots: For this action, device lot numbers are not applicable. The action covers all lots of products distributed between September 2010 and July 2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2823-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2823-2015	Class II	Terminated	Voluntary: Firm initiated	2015-10-07	2015-09-30
Z-2824-2015	Class II	Terminated	Voluntary: Firm initiated	2015-10-07	2015-09-30

Product code OLO

K124004Class IINavigated Cd Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy TapsMedtronic Navigation, Inc. / cleared 2013-03-22

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)