FDASeptember 11, 2020device
Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The 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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
What to do
FDA enforcement status: Ongoing
Brands named
bien air surgery sabienbien air
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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