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U.S. Department of Health and Human Services

Class 2 Device Recall KYPHON(R) Directional Bone Filler Device

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 Class 2 Device Recall KYPHON(R) Directional Bone Filler Devicesee related information
Date Initiated by FirmMay 17, 2017
Create DateJune 03, 2017
Recall Status1 Terminated 3 on June 18, 2019
Recall NumberZ-2247-2017
Recall Event ID 77352
Product Classification Injector, vertebroplasty (does not contain cement) - Product Code OAR
ProductKYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Code Information All Lots
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information ContactEric Epperson
901-344-1435
Manufacturer Reason
for Recall		The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMedtronic distributed a voluntary removal notice (Attachment I) via FedEx courier service to impacted U.S. consignees on 17 May 2017. Communications to impacted consignees outside the United States are currently ongoing per each geographies local procedures. The consignees were directed to do the following: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via fax to 763-367-8134, or via e-mail to rs.sdmriskmgt@medtronic.com. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.
Quantity in Commerce17657 units
Distributionworldwide
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.
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