Reported Oct 28, 2020 · Ongoing
Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been…
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?
- Stryker Instruments REF 5452-007-000 SN *******
- S2 MINI FOOT Pedal - Product UsageThe S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an integrated micromotor, to drive various burs
- Lot codes and dates
- Model 1600983 / Catalog
- number 1600983-001 Serial Numbers
423 of 423 codes
16D000216D000316D000416D000516D000616D000716D000816D000916D001016D001116D001216D001316D001416D001516D001616D001716D001816D001916D002016D002116D002216D002316D002416D002516D002616D002716D002816D002916D003016D003116D003216D003316D003416D003516D003616D003716D003816D003916D004016D004116D004216D004316D004416D004516D004616D004716D004816D004916D005016D005116E000116E000216E000316E000416E000516E000616E000716E000816E000916E0010
- Amount recalled
- Total US = 1120 foot pedals
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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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