Acuity Surgical Devices, LLC: Medical Device Recall in 2020 - (Recall #: Z-2355-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 7, 2019

Date Posted: June 17, 2020

Recall Number: Z-2355-2020

Event ID: 85642

Reason for Recall:

Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.

Status: Ongoing

Product Quantity: A total of 27 lots producing 178 units

Code Information:

Product Product Description Lot Number Number 15-32241207 A Link Z Ti Unitary Open Interbody 32x24x12 7 1000572 15-32241212 A Link Z Ti Unitary Open Interbody 32x24x12 12 1000573 15-32241607 A Link Z Ti Unitary Open Interbody 32x24x16 7 1000576 15-32241612 A Link Z Ti Unitary Open Interbody 32x24x16 12 1000577

Distribution Pattern:

US Nationwide distribution including in the states of TX, FL, NC, LA, KY, WI, SD, IL, CA, and KS. O.U.S.: None

Voluntary or Mandated:

Voluntary: Firm initiated