A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A… — Class II medical device recall Z-2355-2020
Ongoing recall by Acuity Surgical Devices, LLC, reported 2020-06-17, distributed nationwide. Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the sp
| Recall number | Z-2355-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acuity Surgical Devices, LLC, Irving, TX, United States |
| Recall initiated | 2019-01-07 |
| Classified | 2020-06-11 |
| Reported by FDA | 2020-06-17 |
| Distributed | Nationwide (US) |
| Lot numbers | 15-32241207A |
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 for recall
Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2355-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.