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.
This recall has been terminated (originally issued June 19, 2015).
- Company
- Orthofix, Inc
- Recall Initiated
- May 11, 2015
- Posted
- June 19, 2015
- Terminated
- February 17, 2016
- Recall Number
- Z-1819-2015
- Quantity
- 36 units
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.
Lot / Code Info
All lot codes
Root Cause
Device Design
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.