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U.S. Department of Health and Human Services

Class 2 Device Recall Medacta interbody fusion device

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 Class 2 Device Recall Medacta interbody fusion devicesee related information
Date Initiated by FirmMarch 08, 2023
Date PostedApril 19, 2023
Recall Status1 Completed
Recall NumberZ-1403-2023
Recall Event ID 91947
510(K)NumberK221545 
Product Classification Intervertebral fusion device with integrated fixation, lumbar - Product Code OVD
ProductMectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device
Code Information UDI/DI 07630345732316, All Lot Numbers
FEI Number 3006639916
Recalling Firm/
Manufacturer		 Medacta Usa Inc
3973 Delp St
Memphis TN 38118-6110
For Additional Information ContactCustomer 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
ActionMedacta 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 Commerce34 units
DistributionUS: ID, TX, GA, VA, AZ
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.
510(K) Database510(K)s with Product Code = OVD
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