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.
Reported: October 28, 2020 Initiated: September 11, 2020 #Z-0176-2021
Product Description
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.
Reason for Recall
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Details
- Recalling Firm
- Bien-Air Surgery Sa
- Units Affected
- Total US = 1120 foot pedals
- Distribution
- US Nationwide distribution including in the states of CA, MI and MN.
- Location
- Le Noirmont, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bien-Air Surgery Sa. Units affected: Total US = 1120 foot pedals.
Why was this product recalled? ▼
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Moderate. Recall number: Z-0176-2021.
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