# FDA recall Z-2354-2020

> **Acuity Surgical Devices, LLC** · Class II · device recall initiated 2019-01-07.

## Product

A LINK Z INTERVERTEBRAL BODY FUSION DEVICE    Product Description:  A Link Z Ti Unitary Plate-Cage 32x21x15 7  A Link Z Ti Unitary Plate-Cage 32x21x15 12  A Link Z Ti Unitary Plate-Cage 32x21x15 16  A Link Z Ti Unitary Plate-Cage 32x21x15 16  A Link Z Ti Unitary Plate-Cage 32x21x15 16  A Link Z Ti Unitary Plate-Cage 32x21x15 20  A Link Z Ti Unitary Plate-Cage 32x21x15 20  A Link Z Ti Unitary Plate-Cage 32x21x15 20  A Link Z Ti Unitary Plate-Cage 32x21x17 12  A Link Z Ti Unitary Plate-Cage 32x21x17 16  A Link Z Ti Unitary Plate-Cage 32x21x17 20  A Link Z Ti Unitary Plate-Cage 32x21x19 20  A Link Z Ti Unitary Plate-Cage 32x24x15 7  A Link Z Ti Unitary Plate-Cage 32x24x15 16  A Link Z Ti Unitary Plate-Cage 36x26x15 12  A Link Z Ti Unitary Plate-Cage 36x26x15 12  A Link Z Ti Unitary Plate-Cage 36x26x15 16  A Link Z Ti Unitary Plate-Cage 36x26x15 16  A Link Z Ti Unitary Plate-Cage 36x26x15 16  A Link Z Ti Unitary Plate-Cage 36x26x15 16  A Link Z Ti Unitary Plate-Cage 36x26x15 20  A Link Z T

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2354-2020
- **Recalling firm:** Acuity Surgical Devices, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-01-07
- **Report date:** 2020-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2354-2020

## Citation

> AI Analytics. FDA recall Z-2354-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2354-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*