CLASS II Device recall · Reported 1 Jul 2015 · FDA Enforcement Report

Centurion POCT System Drill Guide PN 69-1010 and PN recalled by Orthofix

Orthofix is recalling Orthofix Centurion Poct System Drill Guide PN 69-1010 and PN 69-1012, distributed nationwide in the US. The recall was initiated on 11 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot codes

Quantity recalled36 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1819-2015
FDA event ID: 71262
Recalling firm: Orthofix, Lewisville, TX
Classification: Class II
Status: Terminated
Recall initiated: 11 May 2015
FDA classified: 22 Jun 2015
Reported: 1 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

11 May 2015	Recall initiated by company
22 Jun 2015	Classified by FDA	+42 days
1 Jul 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.

Nationwide California Colorado Florida Idaho Oklahoma Oregon Pennsylvania South Carolina Texas Virginia

Questions about this recall

Is Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012 recalled?

Yes. Orthofix recalled Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012 on 11 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1819-2015.

Why was it recalled?

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.

Which lots are affected?

All lot codes

Where was it sold?

Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Orthofix

All 31

Reported	Class	Recall	Company	Reason	Where
13 Jun 2018Device	CLASS II	Rival Reduce Kit Plates, Sterile recalled by Orthofix	Orthofix	Sterility	19 states
13 Jun 2018Device	CLASS II	Locking Screw, Sterile recalled by Orthofix	Orthofix	Sterility	19 states
13 Jun 2018Device	CLASS II	TN Plate, Sterile recalled by Orthofix	Orthofix	Sterility	19 states
13 Jun 2018Device	CLASS II	Straight Plate, Sterile recalled by Orthofix	Orthofix	Sterility	19 states
13 Jun 2018Device	CLASS II	Box Plate, Sterile recalled by Orthofix	Orthofix	Sterility	19 states

Other Other Medical Devices recalls

All 13,771

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide