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U.S. Department of Health and Human Services

Class 2 Device Recall Rod and screw spinal instrumentation

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 Class 2 Device Recall Rod and screw spinal instrumentationsee related information
Date Initiated by FirmMay 18, 2015
Date PostedJune 10, 2015
Recall Status1 Terminated 3 on October 30, 2015
Recall NumberZ-1749-2015
Recall Event ID 71297
510(K)NumberK130932 
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
ProductORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
Code Information Lot Number S29
Recalling Firm/
Manufacturer		 Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information ContactCustomer Service
888-298-5700
Manufacturer Reason
for Recall		The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOrthofix sent an Urgent Medical Device Recall Notification letter dated May 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Affected customers were instructed to inspect their inventory, and identify and remove the recalled product to send back to Orthofix. The distributors are also instructed to provide recall notification to hospitals, surgeons, or other distributors that they have further distributed affected product to. Contact your local Orthofix representative or Orthofix customer service representative at 888-298-5700 for return instructions and shipment information.
Quantity in Commerce45 units
DistributionUS Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NKB
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