Class 2 Device Recall Medacta interbody fusion device

• Date Initiated by Firm: March 08, 2023
• Date Posted: April 19, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1401-2023
• 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 H12, REF 03.30.301, interbody fusion device
• Code Information: UDI/DI 07630345732293, 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: 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: 53 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