Acuity Surgical Devices Recalls A Link Z Intervertebral Body Fusion Devices
Acuity Surgical Devices is recalling A Link Z Intervertebral Body Fusion Devices due to a manufacturing issue that may prevent vertebral body 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 hazard involves a structural defect in an implanted spinal device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Acuity Surgical Devices, LLC is recalling A Link Z Intervertebral Body Fusion Devices. The recall involves 27 lots producing a total of 178 units. The affected products are spinal devices implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.
The recall is due to a manufacturing process issue that allowed vertebral body bone screws to not seat properly within the spinal device or cage. The affected units 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 United States.
Healthcare providers and patients who have received these devices should contact Acuity Surgical Devices, LLC for further instructions on how to proceed. The specific lot numbers and product codes are listed in the official FDA recall record Z-2355-2020.
The recalled product
- Product
- A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a…
- 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 A Link Z Spinal Fusion Device Recalled for Manufacturing Defect
FDA (Devices) · 2020-06-17
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