Date Initiated by Firm |
March 08, 2023 |
Date Posted |
April 19, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1402-2023 |
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 H14, REF 03.30.302, interbody fusion device |
Code Information |
UDI/DI 07630345732309, 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 |
44 units |
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.
|