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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES

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  Class 2 Device Recall Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES see related information
Date Initiated by Firm March 13, 2018
Create Date May 04, 2018
Recall Status1 Terminated 3 on November 02, 2020
Recall Number Z-1641-2018
Recall Event ID 79667
PMA Number P090029 
Product Classification Prosthesis, intervertebral disc - Product Code MJO
Product Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES:
a) REF 6975205, 5mm
b) REF 6975206, 6mm
c) REF 6975207, 7mm

Product Usage:
The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP Cervical Disc. Medtronic reusable instruments must be sterilized prior to initial use and must be cleaned and sterilized prior to each re-use.
Code Information a) REF 6975205, 5mm; UDI 00643169752979 Lot Number ID17K018 b) REF 6975206, 6mm; UDI 00643169752962  Lot Number ID17J009 c) REF 6975207, 7mm; UDI 00643169752955 Lot Numbers: ID17K007, ID17L035  
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek USA Inc
1800 Pyramid Pl
Memphis TN 38132-1703
For Additional Information Contact Eric Epperson
901-344-1435
Manufacturer Reason
for Recall		 The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
FDA Determined
Cause 2		 Under Investigation by firm
Action Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 13MARCH 2018. The notice requested the following: "Instructions to Customers: 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 of affected product."
Quantity in Commerce 231 units
Distribution US Nationwide Distribution
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.
PMA Database PMAs with Product Code = MJO and Original Applicant = Medtronic Sofamor Danek USA, Inc.
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