Recall Z-2248-2016 ยท JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Steris Corporation
OT1000 Series Orthopedic Surgical Tables
| Date | May 23, 2016 |
| Status | Terminated |
| Reason | STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly. |
| Root cause | Other |
| 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. |
| Quantity | 148 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.