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U.S. Department of Health and Human Services

Class 2 Device Recall OT1000 Series Orthopedic Surgical Tables

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  Class 2 Device Recall OT1000 Series Orthopedic Surgical Tables see related information
Date Initiated by Firm May 23, 2016
Create Date July 20, 2016
Recall Status1 Terminated 3 on August 22, 2016
Recall Number Z-2248-2016
Recall Event ID 74264
Product Classification Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
Product OT1000 Series Orthopedic Surgical Tables
Code Information OT1000, OT1100, and OT1200 Orthopedic Surgical Table
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Kathryn E. Cadorette
440-392-7601
Manufacturer 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 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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