Medacta recalls specific interbody fusion devices due to potential screw breakage. Affected units have UDI/DI 07630345732316 and all lot numbers. No action needed if device is not used.
There is a potential for breakage of the small screw used to affix the anti-backout plate.
Medacta is recalling a specific type of spinal fusion device because a small screw could break, potentially causing the device to fail. This is a low-risk issue that doesn't require immediate action if the device isn't being used.
The small screw that holds the anti-backout plate could break during use, which might cause the device to fail. This could lead to improper spinal fusion if the device doesn't stay in place.
Patients who have received the MectaLIF Anterior Lag Plate Flush H16 device with UDI/DI 07630345732316 are affected. Surgeons and medical staff using this device during procedures are at higher risk.
Check for the UDI/DI number 07630345732316 on the device. All lot numbers of this specific interbody fusion device are affected.
If you have the MectaLIF Anterior Lag Plate Flush H16 device with UDI/DI 07630345732316, confirm it is not in use.
No, the recall is for devices that have been implanted or are being used. If the device is not in use, no action is needed.
If you have the device and it is not in use, no action is required. Contact your surgeon if you have had the device implanted.
Look for the UDI/DI number 07630345732316 on the device. All lot numbers of this specific interbody fusion device are affected.
We’ve drafted a message you can send Medacta to request your refund or repair — edit it as you like.
Subject: Recall Z-1403-2023 — Medacta Medacta Hello, I own a Medacta that is covered by recall Z-1403-2023 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.
