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 Medacta interbody fusion device

  • 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 Medacta interbody fusion device see related information
Date Initiated by Firm March 08, 2023
Date Posted April 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-1404-2023
Recall Event ID 91947
510(K)Number K221545  
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
Product MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device
Code Information UDI/DI 07630345732323, All Lot Numbers
Recalling Firm/
Manufacturer		 Medacta Usa Inc
3973 Delp St
Memphis TN 38118-6110
For Additional Information Contact Customer Service
312-878-2381
Manufacturer Reason
for Recall		 There is a potential for breakage of the small screw used to affix the anti-backout plate.
FDA Determined
Cause 2		 Under Investigation by firm
Action Medacta USA initially notified its direct consignees by telephone on 03/08/2023 and followed with an URGENT - Field Safety Notice sent by email on 03/22/2023. The notice explained the issue and requested the units be returned and the notice be sent forward to all people and organizations potentially affected.
Quantity in Commerce 17 unis
Distribution US: ID, TX, GA, VA, AZ
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OVD and Original Applicant = Medacta International S.A.
-
-