Recall Z-1819-2015 ยท FZX Guide, Surgical, Instrument
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.
| Date | Jun 19, 2015 (initiated May 11, 2015) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.