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U.S. Department of Health and Human Services

Class 2 Device Recall Firebird Spinal Fixation System

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  Class 2 Device Recall Firebird Spinal Fixation System see related information
Date Initiated by Firm January 08, 2016
Date Posted February 11, 2016
Recall Status1 Terminated 3 on November 16, 2016
Recall Number Z-0797-2016
Recall Event ID 73069
510(K)Number K151488  
Product Classification Wrench - Product Code HXC
Product Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512)

Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
Code Information BS535418105, BS535419118, BS535420030,  BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039,  BS535418127,  BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and  BS562325023.
Recalling Firm/
Manufacturer		 Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information Contact Christopher Hack
214-937-2828
Manufacturer Reason
for Recall		 There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
FDA Determined
Cause 2		 Component design/selection
Action Affected consignees were notified via an Urgent Medical Device Recall Notification letter, dated 1/8/16. The letter identified the affected device and stated the reason for the recall. The recalling firm requests customers to remove the affected devices from their inventory and cease further distribution or use. Customers whom the devices were further distributed to should be notified that the affected devices cannot be used and must be returned to Orthofix per the instructions provided. The attached Acknowledgement Form should be completed and returned. Customers can contact their local Orthofix representative or customer service for further information, replacements, or disposal instructions.
Quantity in Commerce 36 units
Distribution Worldwide Distribution -- US, Spain, Italy, and Australia.
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.
510(K) Database 510(K)s with Product Code = HXC and Original Applicant = Orthofix, Inc.
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