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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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
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