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

Recall Z-0657-2014 — REF IMRI-MOTORiMRI Handpiece. Use with iMRI System OnlyRx OnlyManufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

U.S. FDA — Device Enforcement · United States · 2013-04-25 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0657-2014
Date of alert: 2013-04-25
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 firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..

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-0657-2014 — ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

Related

Recall Z-0657-2014 — REF IMRI-MOTORiMRI Handpiece. Use with iMRI System OnlyRx OnlyManufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.