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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Acuity Surgical Devices, LLC
- Category
- Medical Device — Spinal Implant
Distribution
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 →Related recalls
Same manufacturer · Acuity Surgical Devices, LLC
See all →- HighAcuity Surgical Devices Recalls A Link Z Intervertebral Body Fusion Devices
FDA (Devices) · 2020-06-17
Same hazard · structural defect
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