Device 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.
Z-1819-2015
Product summary
- Firm
- Orthofix, Inc
- Event
- Event 71262
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36 units
- Official record key
device-enforcement:Z-1819-2015
Official wording
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.
Code information: All lot codes
Distribution pattern: Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.
Derived failure modes
-
Unknown
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.