Recall Z-1819-2015— Orthofix, Inc
Class II · Terminated
Class II FDA medical device recall by Orthofix, Inc, initiated 2015-05-11, terminated 2016-02-17. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Orthofix, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-11
- Terminated
- 2016-02-17
- Firm location
- Lewisville, TX, United States
Product description
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.