—#147015

Product

OT1000 Series Orthopedic Surgical Tables

FDA product code: JEA — Table, Surgical With Orthopedic Accessories, Ac-Powered
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: OT1000, OT1100, and OT1200 Orthopedic Surgical Table

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.

Root cause (FDA determination)

Other

Action the firm took

Recall Notification Letters to the affected Consignees was sent on May 23, 2016 via FedEx with tracking numbers for delivery confirmation. STERIS Field Service Technicians will visit each domestic Customer location to perform the inspection and reinstallation of the pivot pin assemblies. For international direct accounts who have further distributed the surgical table, Steris asked to identify the Customers, and to notify them of this product field correction, and that not to operate the tables until the inspection has been done of the pivot pin assembly on all affected tables.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-05-23
Terminated: 2016-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.