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Terminated

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.

FDA Recall Z-1819-2015 · Posted 2015-06-19

Recalling FirmOrthofix, Inc
Recall StatusTerminated
Product CodeFZX
Date Initiated2015-05-11
Date Terminated2016-02-17
Product Quantity36 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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