Z-1641-2018Class II

Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205...

Name: Z-1641-2018 Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2018-03-13
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2018-03-13 / Terminated

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product... on 2018-03-13. FDA classified it as Class II and gives the reason as "The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1641-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-13
Posted: 2018-05-04
Terminated: 2020-11-02
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
Product code: MJO Prosthesis, Intervertebral Disc
Reason for recall: The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
FDA root cause: Under Investigation by firm
Action: Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 13MARCH 2018. The notice requested the following: "Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via fax to 763-367-8134, or via e-mail to [email protected]. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return of affected product."
Quantity in commerce: 231 units
Distribution: US Nationwide Distribution
Product codes and lots: a) REF 6975205, 5mm; UDI 00643169752979 Lot Number ID17K018 b) REF 6975206, 6mm; UDI 00643169752962 Lot Number ID17J009 c) REF 6975207, 7mm; UDI 00643169752955 Lot Numbers: ID17K007, ID17L035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1641-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1641-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code MJO

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)