The Recall Desk
SevereFDA (Devices)·Z-1149-2021·Announced 2021-03-03

Steris Recalls OT1000 Series Orthopedic Surgical Tables Due to Bond Separation

Steris is recalling 272 OT1000 Series Orthopedic Surgical Tables because a glued bond may separate, potentially causing unexpected movement during procedures.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural vehicle defect (structural defect in a medical device) that could cause unexpected movement during a patient procedure, meeting the criteria for a Severe rating.

Plain-English summary

Steris Corporation is recalling 272 OT1000 Series Orthopedic Surgical Tables, including models OT1000, OT1100, and OT1200. The recall was initiated after the company identified on January 7, 2021, that the glued bond between the beam and the leg spar assembly may begin to separate over time.

This defect could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure. The affected units were distributed domestically across numerous US states and territories, as well as in Canada, South Korea, Panama, Qatar, and Thailand.

Healthcare facilities should contact Steris Corporation for instructions on how to address the defect and ensure patient safety.

The recalled product

Product
OT1000 Series Orthopedic Surgical Tables
Manufacturer
Steris Corporation
Category
Medical Device — Surgical Tables
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model No.: OT1000
  • OT1100
  • OT1200

Distribution

Distributed in 40 states:

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