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

Recall Z-0578-2014 — ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .

U.S. FDA — Device Enforcement · United States · 2013-11-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0578-2014
Date of alert: 2013-11-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Materialise USA LLC
Product category: device
Product type: Devices

Reported risk: Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.

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.

Recall Z-0578-2014 — ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .

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