Home / Recalls / Bien-Air Surgery Sa / Z-0178-2021

Z-0178-2021 Class II Ongoing

Recalled by Bien-Air Surgery Sa — Le Noirmont, N/A

Recall Details

Product Type
Devices
Report Date
October 28, 2020
Initiation Date
September 11, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Total US = 1120 foot pedals

Product Description

Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery.

Reason for Recall

The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.

Distribution Pattern

US Nationwide distribution including in the states of CA, MI and MN.

Code Information

Model 1600686 / Catalog number 1600686-001 Serial Numbers: 18D0006 18D0007 18D0008 18D0009 18D0010 18D0013 18D0014 18D0015 18D0016 18D0017 18D0018 18D0019 18D0020 18D0021 18D0022 18D0023 18D0024 18D0025 18D0026 18D0027 18D0028 18D0029 18D0030 16A0005 16A0009 16A0010 16A0011 16A0014 17D0011 17G0006

Other recalls by Bien-Air Surgery Sa

  • Z-0179-2021 Class II — Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product U (September 11, 2020)
  • Z-0177-2021 Class II — Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Produ (September 11, 2020)
  • Z-0180-2021 Class II — Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage (September 11, 2020)
  • Z-0176-2021 Class II — Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: inte (September 11, 2020)