Medacta recalls MectaLIF Anterior Lag Plate Flush H18 (REF 03.30.3:04) due to potential screw breakage during spinal fusion surgery. Affected units have specific UDI/DI numbers and lot numbers.
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Medacta is recalling a spinal fusion device called MectaLIF Anterior Lag Plate Flush H18 because there's a risk of the small screw breaking. This could lead to complications during surgery if the device fails to stay securely in place.
The small screw that holds the anti-backout plate in place could break during spinal fusion surgery. If the screw breaks, the device might not stay securely in place, potentially causing complications during the procedure.
Patients who have undergone spinal fusion surgery using this specific device model are likely affected. Surgeons and medical staff who use the device during procedures are at higher risk.
Check for the product name 'MectaLIF Anterior Lag Plate Flush H18' with reference number 03.30.304. The device has a unique identifier (UDI/DI) starting with 07630345732323 and all lot numbers.
Look for the product name and reference number on the device packaging or label.
The recall states there is a potential for screw breakage during spinal fusion surgery, which could lead to complications if the device fails to stay securely in place.
Check for the product name 'MectaLIF Anterior Lag Plate Flush H18' with reference number 03.30.304 and unique identifier starting with 07630345732323.
The recall does not specify a remedy, so contact Medacta directly for further instructions.
We’ve drafted a message you can send Medacta to request your refund or repair — edit it as you like.
Subject: Recall Z-1404-2023 — Medacta Medacta Hello, I own a Medacta that is covered by recall Z-1404-2023 from Medacta. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.