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U.S. Department of Health and Human Services

Class 2 Device Recall Manual General Surgery Drill Guide

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  Class 2 Device Recall Manual General Surgery Drill Guide see related information
Date Initiated by Firm May 11, 2015
Date Posted June 19, 2015
Recall Status1 Terminated 3 on February 17, 2016
Recall Number Z-1819-2015
Recall Event ID 71262
Product Classification Guide, surgical, instrument - Product Code FZX
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.
Code Information All lot codes
Recalling Firm/
Manufacturer		 Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information Contact Customer Service
888-298-5700
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 36 units
Distribution Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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