FDA Device recall Z-1819-2015
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012
- FDA Device
- Class II
- terminated
- Published 2015-07-01
On 2015-07-01 the FDA classified a Class II recall of ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012 by Orthofix, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1819-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-11 |
| Published | 2015-07-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthofix |
| Distribution | US |
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.
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.
Identifiers
| code_info | All lot codes |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1819-2015%22
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