FDA Device recall Z-2355-2020
A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Inte…
- FDA Device
- Class II
- ongoing
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class II recall of A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Inte… by Acuity Surgical Devices, citing due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2355-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-01-07 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Acuity Surgical Devices |
| Distribution | US |
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.
Reason
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Identifiers
| code_info | Product Product Description Lot Number Nu…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2355-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.