The Recall Desk
HighFDA (Devices)·Z-2354-2020·Announced 2020-06-17

Acuity A Link Z Spinal Fusion Device Recalled for Manufacturing Defect

Acuity Surgical Devices is recalling 178 A Link Z intervertebral body fusion devices because a manufacturing issue prevented bone screws from seating properly.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a structural failure risk in an implanted spinal device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Acuity Surgical Devices, LLC is recalling 178 units of the A Link Z Intervertebral Body Fusion Device. The recall covers 27 lots of titanium unitary plate-cages and open interbodies in various sizes. These devices are implanted in the intervertebral body space via an anterior approach to improve spinal stability while supporting fusion.

The recall was initiated due to a manufacturing process issue that allowed vertebral body bone screws to not seat properly within the spinal device or cage. This defect could compromise the stability of the implant.

The affected devices were distributed nationwide in the United States, including in Texas, Florida, North Carolina, Louisiana, Kentucky, Wisconsin, South Dakota, Illinois, California, and Kansas. No units were distributed outside the U.S. Patients who have had these devices implanted should contact their healthcare provider for evaluation.

The recalled product

Product
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x
Manufacturer
Acuity Surgical Devices, LLC
Category
Medical Device — Spinal Implant
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Acuity Surgical Devices, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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