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

Recall Z-0176-2021 — Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

U.S. FDA — Device Enforcement · Switzerland · 2020-09-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0176-2021
Date of alert
2020-09-11
Country / jurisdiction
Switzerland
Risk level
Class II
Risk type
recall
Brand
Bien-Air Surgery Sa
Product category
device
Product type
Devices
Reported risk: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
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.

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