Reported Oct 28, 2020 · Ongoing
Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System…
Bien-Air Surgery Sa
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bien-Air Surgery Sa · rue de l' ouest 2b · Le Noirmont, N/A · N/A
Is this the product you have?
- Entellus Medical REF SSA-102 SN ******* Shaver
- System Foot Pedal - Product UsageThe Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology
- Lot codes and dates
- Model 1600998 / Catalog
- number 1600998-001 Serial Numbers
516 of 516 codes
17K005919A004216H000116H000216H000316H000416H000516H000616H000716H000816H000916H001016H001116H001216H001316H001416H001516H001616H001716H001816H001916H002016H002116H002216H002316H002416H002516J000116J000216J000316J000416J000516J000616J000716J000816J000916J001016J001116J001216J001316J001416J001516J001616J001716J001816J001916J002016J002116J002216J002316J002416J002516J002616J002716J002816J002916J003016L000116L000216L0003
- Amount recalled
- N/A
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Bien-Air Surgery Sa recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.