Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

OT1000 Series Orthopedic Surgical Tables

FDA Recall Z-2248-2016 · Posted None

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeJEA
Date Initiated2016-05-23
Date Terminated2016-08-22
Product Quantity148

Reason for Recall

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

Firm Action

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.

Root Cause

Other

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑