Orthofix, Inc: Medical Device Recall in 2015 - (Recall #: Z-1819-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 11, 2015

Date Posted: July 1, 2015

Recall Number: Z-1819-2015

Event ID: 71262

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.

Status: Terminated

Product Quantity: 36 units

Code Information:

All lot codes

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated