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Acuity Surgical Devices, LLC recalls A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Lin
Recalled June 17, 2020 · FDA recall Z-2355-2020 · Acuity Surgical Devices
Hazard
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage. · FDA Class II
Units
A total of 27 lots producing 178 units
Sold at
US Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS. O.U.S.: None
Description
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
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 spinal device that is implanted in the intervertebral body space via an anterior approach to improve stability of the spine while supporting fusion.
Manufacturer(s)
Acuity Surgical Devices, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →