Z-0566-2018Class II

Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only

Name: Z-0566-2018 Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Creator: Medtronic Sofamor Danek USA Inc
Published: 2017-12-22
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2017-12-22 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only on 2017-12-22. FDA classified it as Class II and gives the reason as "Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification". 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-0566-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-22
Posted: 2018-02-09
Terminated: 2018-07-31
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by letter on 12/22/2017, requesting the return of the product.
Quantity in commerce: 2 units
Distribution: MN, NC
Product codes and lots: UDI: 00643169363502, Lot Number EM17F015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0566-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0566-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-09

Product code MDM

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