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

Recall Z-1174-2014 — Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable

U.S. FDA — Device Enforcement · United States · 2014-01-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1174-2014
Date of alert: 2014-01-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes, Inc.
Product category: device
Product type: Devices

Reported risk: Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.

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.

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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