Z-2248-2016Class II

OT1000 Series Orthopedic Surgical Tables

Name: Z-2248-2016 OT1000 Series Orthopedic Surgical Tables
Creator: Steris Corporation
Published: 2016-05-23
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2016-05-23 / Terminated

FDA source

Steris Corporation began a recall of OT1000 Series Orthopedic Surgical Tables on 2016-05-23. FDA classified it as Class II and gives the reason as "STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2248-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-23
Posted: 2016-07-20
Terminated: 2016-08-22
Recalling firm: STERIS Corporation
Product: OT1000 Series Orthopedic Surgical Tables
Product code: JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
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 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 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.
Product codes and lots: OT1000, OT1100, and OT1200 Orthopedic Surgical Table

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2248-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2248-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-27	2016-07-20

Product code JEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)