Z-1819-2015Class II

ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with...

Name: Z-1819-2015 ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with...
Creator: Orthofix, Inc
Published: 2015-05-11
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2015-05-11 / Terminated / root cause: design

FDA source

Orthofix, Inc began a recall of ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure... on 2015-05-11. FDA classified it as Class II and gives the reason as "There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1819-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-11
Posted: 2015-06-19
Terminated: 2016-02-17
Recalling firm: Orthofix SRL
Product: ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
Product code: FZX Guide, Surgical, Instrument
Reason for recall: There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.
Root cause tag: design
FDA root cause: Device Design
Action: Orthofix sent an Urgent Medical Device Product Advisory Notification letter dated May 11, 2015, to the affected distributors and hospitals. The consignees were directed to inspect thier inventory and perform checks before surgical use of the drill guides. Customers were instructed to provide a copy of the Product Advisory Notification letter if product was further distributed. Customers with questions were instructed to contact their local Orthofix representative and to for returns they should contact Orthofix customer service representative at 888-298-5700.
Quantity in commerce: 36 units
Distribution: Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1819-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1819-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-01	2015-06-22

Product code FZX

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)