Bien-Air Surgery recalls
Bien-Air Surgery has 5 recalls on record with the FDA and USDA, the earliest in 2020 and the latest reported on 28 Oct 2020. 5 are still ongoing.
Total recalls5since 2020
Last 12 months0reported
Class I00% of total
Ongoing5latest 28 Oct 2020
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 5 100%Class III 0 0%
Why bien-air surgery is recalled
Product types
By year
Ongoing bien-air surgery recalls
5 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stryker Instruments recalled by Bien-Air Surgery | Bien-Air Surgery | Other | Nationwide |
| Device | CLASS II | Entellus Medical recalled by Bien-Air Surgery | Bien-Air Surgery | Other | Nationwide |
| Device | CLASS II | Bien-Air Surgery REF 1600407-001 SN **** Footctrl Osseodoc - Product recalled | Bien-Air Surgery | Other | Nationwide |
| Device | CLASS II | Bien-Air Surgery REF 1600686-001 SN ******* Osseostap Footcontrol recalled | Bien-Air Surgery | Other | Nationwide |
| Device | CLASS II | Bien-Air Surgery REF 1600517-001 SN ******* Multifunction Pedal recalled | Bien-Air Surgery | Other | Nationwide |
All bien-air surgery recalls, newest first
5 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Stryker Instruments recalled by Bien-Air Surgery | Bien-Air Surgery | Other | Nationwide |
| Device | CLASS II | Entellus Medical recalled by Bien-Air Surgery | Bien-Air Surgery | Other | Nationwide |
| Device | CLASS II | Bien-Air Surgery REF 1600407-001 SN **** Footctrl Osseodoc - Product recalled | Bien-Air Surgery | Other | Nationwide |
| Device | CLASS II | Bien-Air Surgery REF 1600686-001 SN ******* Osseostap Footcontrol recalled | Bien-Air Surgery | Other | Nationwide |
| Device | CLASS II | Bien-Air Surgery REF 1600517-001 SN ******* Multifunction Pedal recalled | Bien-Air Surgery | Other | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.