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

Recall Z-0199-2014 — Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone

U.S. FDA — Device Enforcement · United States · 2011-05-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0199-2014
Date of alert: 2011-05-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: The Anspach Effort, Inc.
Product category: device
Product type: Devices

Reported risk: Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th

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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