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

Recall Z-0395-2014 — Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

U.S. FDA — Device Enforcement · United States · 2012-09-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0395-2014
Date of alert
2012-09-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes USA HQ, Inc.
Product category
device
Product type
Devices
Reported risk: This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.
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.

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