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

Recall Z-0393-2014 — Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spac

U.S. FDA — Device Enforcement · United States · 2013-10-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0393-2014
Date of alert: 2013-10-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes USA HQ, Inc.
Product category: device
Product type: Devices

Reported risk: One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.

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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