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

Recall Z-2107-2018 — MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology

U.S. FDA — Device Enforcement · United States · 2018-04-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2107-2018
Date of alert: 2018-04-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: MicroAire Surgical Instruments, LLC
Product category: device
Product type: Devices

Reported risk: The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.

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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