—#185584

Product

OT1000 Series Orthopedic Surgical Tables

FDA product code: JEA — Table, Surgical With Orthopedic Accessories, Ac-Powered
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Model No.: OT1000, OT1100, OT1200

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-01-21
Terminated: 2021-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185584. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.