Recall Z-1149-2021
Steris Corporation · initiated January 21, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OT1000 Series Orthopedic Surgical Tables
Codes / lots: Model No.: OT1000, OT1100, OT1200
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.
FDA-determined 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.
Details
- Recall number
- Z-1149-2021
- Initiated
- January 21, 2021
- Terminated
- November 10, 2021
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- Quantity
- 272 tables total (Domestic: 227 tables, Foreign 45 tables)
- 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.
- Recalling firm
- Steris Corporation, Mentor, OH