Medacta recalls MectaLIF Anterior Lag Plate Flush H12 (REF 03.30.3:01) 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 that may break the small screw holding the anti-backout plate. This could lead to complications during surgery if the screw fails under stress.
The small screw that secures the anti-backout plate could break during spinal fusion surgery. If the screw breaks, it might cause the plate to become loose or misaligned, potentially affecting the surgery's outcome.
Surgical patients who received the MectaLIF Anterior Lag Plate Flush H12 device with the specified UDI/DI number and lot numbers. Surgeons and medical teams using this device are most at risk during procedures.
Check for the UDI/DI number 07630345732293 and lot numbers on the device. This specific model was sold with the reference number REF 03.30.301 for interbody fusion procedures.
Look for the UDI/DI number 07630345732293 and lot numbers on the device.
The recall states there is a potential for screw breakage during surgery, which could affect the procedure. However, the risk is not described as causing serious injury in normal use.
Check for the UDI/DI number 07630345732293 and lot numbers on the device. This model was sold with reference number REF 03.30.301 for interbody fusion procedures.
The recall does not specify a remedy, so no action is required beyond checking the device details.
We’ve drafted a message you can send Medacta to request your refund or repair — edit it as you like.
Subject: Recall Z-1401-2023 — Medacta Medacta Hello, I own a Medacta that is covered by recall Z-1401-2023 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.
