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 DirectInject

  • 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 DirectInjectsee related information
Date Initiated by FirmApril 01, 2021
Create DateApril 19, 2021
Recall Status1 Terminated 3 on December 19, 2022
Recall NumberZ-1436-2021
Recall Event ID 87684
510(K)NumberK143661 
Product Classification Methyl methacrylate for cranioplasty - Product Code GXP
ProductDirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.
Code Information Lot: DI20311,DI20307  Product Code (UDI): 07613327123265
FEI Number 3002821504
Recalling Firm/
Manufacturer		 Stryker Leibinger GmbH & Co. KG
Botzinger Str. 41
Freiburg Im Breisgau Germany
For Additional Information ContactHans Geiger
269-3892323 Ext. 0
Manufacturer Reason
for Recall		Inability for the user to inject the paste from the syringe into the target location.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 04/01/2021, Stryker issued an Urgent Medical Device Removal notice via letter informing customers that users have reported the inability to push the paste through the Mixer-Cannula which prohibits the injection into a bone void.
Quantity in Commerce321 units
DistributionWorldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
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 = GXP
-
-