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U.S. Department of Health and Human Services

Class 2 Device Recall InflateFX" Gen II Fracture Management, Medtronic Bone Void Filler

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  Class 2 Device Recall InflateFX" Gen II Fracture Management, Medtronic Bone Void Filler see related information
Date Initiated by Firm April 24, 2020
Create Date June 16, 2020
Recall Status1 Terminated 3 on March 31, 2021
Recall Number Z-2391-2020
Recall Event ID 85611
510(K)Number K981251  K010246  K041454  
Product Classification Arthroscope - Product Code HRX
Product Medtronic Bone Void Filler, Large - Product Usage:
is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
Code Information Product number: C07B;   GTIN: 00813845020511;   Lot Number: 1127302 
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		 Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
FDA Determined
Cause 2		 Under Investigation by firm
Action Medtronic notified customers on about 04/24/2020 via "URGENT: Voluntary Market Removal (Recall)" letter. Customers were informed that Medtronic was notified by Skeletal Kinetics LLC that product that may not maintain its setting characteristics for the labeled shelf-life duration of the product, which may lead to a longer period of time required for the product to set at the time of implantation. Instructions included to not use the product and locate and removed the impacted product from inventory, complete the provided Customer Confirmation Form and return it via email to rs.sdmriskmgt@medtronic.com, and contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.
Quantity in Commerce 6 units
Distribution Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.
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 = HRX and Original Applicant = KYPHON, INC.
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