Recall Z-1149-2021— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2021-01-21, terminated 2021-11-10. FDA's recall record names no specific 510(k) clearance for this event. Product: OT1000 Series Orthopedic Surgical Tables. Reason: 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..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-21
- Terminated
- 2021-11-10
- Firm location
- Mentor, OH, United States
Product description
OT1000 Series Orthopedic Surgical Tables
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.