Medical device recalls Moderate risk

Steris Corporation recalls OT1000 Series Orthopedic Surgical Tables

Recall date
May 23, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2248-2016
FDA classification
Class II
Brand / firm
Steris Corporation
Sold / distributed
AL;AK, AZ; AR; CA; CO; CT; DC; FL; GA; IL; IN; IA; NY; NJ; NC; OH; OK; OR; PA; PR; SC; TX; UT and VA. Foreign accounts: Canada; France; Korea; Panama; Qatar and Thailand.

Why it was recalled

STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OT1000 Series Orthopedic Surgical Tables

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