FDA Medical Device Recalls (openFDA)
Orthofix, Inc: 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.
- Recall number
- Z-1819-2015
- Recalling firm
- Orthofix, Inc
- 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 procedure of bone preparation.
- Status
- Terminated
- Initiated
- 2015-05-11
- Posted
- 2015-06-19
- Terminated
- 2016-02-17
- Reason
- 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.
- Root cause
- Device Design
- 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.
- Quantity
- 36 units
- Distribution
- Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.
- Lot, serial or model codes
- All lot codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZX
- Firm FEI
- 2183449
- Firm city
- Lewisville
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28