Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2354-2020 — 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 U

U.S. FDA — Device Enforcement · United States · 2019-01-07 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2354-2020
Date of alert
2019-01-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Acuity Surgical Devices, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
32211507
Reported risk: Due to a manufacturing process issue, it allowed vertebral body bone screws to not seat properly within the spinal device/cage.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.