Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall INFUSE Bone Graft X SMALL KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall INFUSE Bone Graft X SMALL KIT see related information
Date Initiated by Firm September 27, 2018
Create Date November 09, 2018
Recall Status1 Terminated 3 on September 16, 2020
Recall Number Z-0440-2019
Recall Event ID 81171
PMA Number P000058 P050053 
Product Classification Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction - Product Code NEK
Product INFUSE Bone Graft X SMALL KIT REF 7510100
Code Information UDI 00613994239525, Lot Number M111806AAA
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 Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
FDA Determined
Cause 2		 Error in labeling
Action The firm initiated the recall by letter on 09/27/2018. The firm will coordinate the return of the recalled product.
Quantity in Commerce 138 units
Distribution US
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 = NEK and Original Applicant = Medtronic Sofamor Danek USA, Inc.
-
-