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

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 i — recall Z-2355-2020

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

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2355-2020
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): 32241207

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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.

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