FDAClass IIJuly 1, 2015

ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 recall

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…

Why was ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lot codes

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…
Recalling firm
Orthofix, Inc
Quantity
36 units
Distribution
Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.
Recall date
July 1, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls