Acuity Surgical Devices recalls A Link Z spinal fusion devices due to potential improper screw seating in the spinal cage. Affected units include specific sizes and lot numbers. No remedy is provided in the recall notice.
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Acuity Surgical Devices is recalling certain A Link Z spinal fusion implants because manufacturing issues may cause the bone screws to not seat properly in the spinal cage. This could lead to improper spinal fusion and potential complications after surgery.
The manufacturing process issue means the bone screws might not sit correctly within the spinal cage. This could cause the implant to shift or fail during spinal fusion, potentially leading to complications like pain, instability, or the need for additional surgery.
Patients who received the recalled A Link Z spinal fusion devices during surgery are most at risk. The recall covers specific model sizes and lot numbers produced between 2014 and 2015.
Check if your device is listed in the product descriptions and lot numbers provided in the recall notice. The affected models include specific sizes like 32x21x15, 32x24x15, and 36x26x15 with lot numbers from 14-32211507 to 15-32241612.
Reach out to Acuity Surgical Devices directly to confirm if your device is affected and get guidance on next steps.
The recall is due to a manufacturing issue that may cause the bone screws to not seat properly within the spinal cage, potentially leading to improper spinal fusion.
The affected models include specific sizes like 32x21x15, 32x24x15, and 36x26x15 with lot numbers from 14-32211507 to 15-32241612.
The recall notice does not specify any remedy or corrective action.
We’ve drafted a message you can send Acuity Surgical Devices to request your refund or repair — edit it as you like.
Subject: Recall Z-2354-2020 — Acuity Surgical Devices Acuity Surgical Devices Hello, I own a Acuity Surgical Devices that is covered by recall Z-2354-2020 from Acuity Surgical Devices. 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.
