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

Recall Z-1911-2014 — ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

U.S. FDA — Device Enforcement · United States · 2012-11-28 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1911-2014
Date of alert
2012-11-28
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
The Anspach Effort, Inc.
Product category
device
Product type
Devices
Reported risk: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.