Z-1149-2021Class II

OT1000 Series Orthopedic Surgical Tables

Name: Z-1149-2021 OT1000 Series Orthopedic Surgical Tables
Creator: Steris Corporation
Published: 2021-01-21
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2021-01-21 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation began a recall of OT1000 Series Orthopedic Surgical Tables on 2021-01-21. FDA classified it as Class II and gives the reason as "On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1149-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-21
Posted: 2021-02-24
Terminated: 2021-11-10
Recalling firm: STERIS Corporation
Product: OT1000 Series Orthopedic Surgical Tables
Product code: JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
Reason for recall: On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: In January, 2021, Steris will issue an Urgent Medical Device Correction notice to customers via letter for the OT1000 Series Orthopedic Surgical Table. Steris has identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure.
Quantity in commerce: 272 tables total (Domestic: 227 tables, Foreign 45 tables)
Distribution: Domestic: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL IN, IW, KS, KY, LA, ME, MD, MI, MN, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, PR, SC, TX, UT, VT, VA, WA, WV, WI. Foreign: Canada, South Korea, Panama, Qatar, Thailand.
Product codes and lots: Model No.: OT1000, OT1100, OT1200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1149-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1149-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)