OT1000 Series Orthopedic Surgical Tables
- Company
- Steris Corporation
- Recall Initiated
- January 21, 2021
- Terminated
- November 10, 2021
- Recall Number
- Z-1149-2021
- Quantity
- 272 tables total (Domestic: 227 tables, Foreign 45 tables)
- Firm Location
- Mentor, OH
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.
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.
Lot / Code Info
Model No.: OT1000, OT1100, OT1200
Root Cause
Process control
Action Taken
In January, 2021, Steris will issue an Urgent Medical Device Correction notice to customers via letter for the OT1000 Series Orthopedic Surgical Table. Steris has 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.