Acuity Surgical recalls A Link Z spinal fusion devices due to potential improper screw seating causing instability. Affected units have specific model sizes and lot numbers. Consumers should contact the manufacturer for details.
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Acuity Surgical is recalling certain A Link Z spinal fusion devices 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 instability after surgery.
The device's bone screws may not seat correctly in the spinal cage during surgery. This could cause the device to become unstable after implantation, potentially leading to improper spinal fusion and complications.
Patients who received the recalled A Link Z spinal fusion devices during surgery are most at risk. The recall affects specific model sizes and lot numbers produced between certain dates.
Check the product label for model sizes: 32x24x12 (7 or 12) or 32x24x16 (7 or 12). Look for lot numbers 15-32241207, 15-32241212, 15-32241607, or 15-32241612.
Reach out to Acuity Surgical Devices, LLC for specific details about your device and instructions on next steps.
Due to a manufacturing process issue, the bone screws may not seat properly within the spinal device/cage, potentially causing instability.
The affected models are A Link Z Ti Unitary Open Interbody 32x24x12 (7 or 12) and 32x24x16 (7 or 12).
Check the product label for model sizes and lot numbers: 15-32241207, 15-32241212, 15-32241607, or 15-32241612.
We’ve drafted a message you can send Acuity Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-2355-2020 — Acuity Surgical Acuity Surgical Hello, I own a Acuity Surgical that is covered by recall Z-2355-2020 from Acuity Surgical. 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.
