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

Recall Z-1989-2015 — Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spi

U.S. FDA — Device Enforcement · United States · 2015-06-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1989-2015
Date of alert: 2015-06-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alliance Partners LLC
Product category: device
Product type: Devices

Reported risk: Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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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