Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1149-2021 — OT1000 Series Orthopedic Surgical Tables

U.S. FDA — Device Enforcement · United States · 2021-01-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1149-2021
Date of alert
2021-01-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Steris Corporation
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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