Recall Z-2248-2016
Steris Corporation · initiated May 23, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OT1000 Series Orthopedic Surgical Tables
Codes / lots: OT1000, OT1100, and OT1200 Orthopedic Surgical Table
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-2248-2016
- Initiated
- May 23, 2016
- Terminated
- August 22, 2016
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- 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.
- Recalling firm
- Steris Corporation, Mentor, OH