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TM "Rehabilitimed" RS-B12 L Comfort

REABILITIMED TOV · Model RS-B12 L Comfort · UDI-DI 04823097716441

ITW
1
510(k) clearances
70
Adverse events
3
Recalls
460
Facilities

Description

It is a knitted ankle bandage, article number RS-B12, graphite color, with a turquoise pattern. Made of nylon and elastane, reinforced with silicone inserts.

Recalls

DateFirmReason
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound
2015-04-13United Surgical AssociatesThe product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.