FDA Device recall Z-0178-2021
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy…
- FDA Device
- Class II
- ongoing
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class II recall of Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy… by Bien Air Surgery, citing the magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0178-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-11 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bien Air Surgery |
| Distribution | US |
Product
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
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
Identifiers
| code_info | Model 1600686 / Catalog number 1600686-001 Serial Numbers: 18D0006 18D0007 18D0008 18D0009 18D0010 18D0013 18D0…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0178-2021%22
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