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

Recall Z-0226-2015 — Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5).

U.S. FDA — Device Enforcement · United States · 2014-10-23 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0226-2015
Date of alert: 2014-10-23
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Synthes (USA) Products LLC
Product category: device
Product type: Devices

Reported risk: Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.

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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