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

FDA device recall Z-1819-2015 · posted 2015-06-19 · Terminated

Recall details

Recalling firm

Orthofix, Inc

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.

Action taken

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

Status

Terminated

Product code

FZX

Quantity affected

36 units

Distribution

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

Date initiated

2015-05-11

Date posted

2015-06-19

Date terminated

2016-02-17

Location

Lewisville, TX