FDAClass IIMarch 3, 2021

OT1000 Series Orthopedic Surgical Tables recall

OT1000 Series Orthopedic Surgical Tables

Why was OT1000 Series Orthopedic Surgical Tables recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No.: OT1000, OT1100, OT1200

Product
OT1000 Series Orthopedic Surgical Tables
Recalling firm
Steris Corporation
Quantity
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.
Recall date
March 3, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls