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Recall Observatory FDA recall evidence

Device product

OT1000 Series Orthopedic Surgical Tables

Z-1149-2021

January 21, 2021

Class II

Product summary

Firm
Steris Corporation
Event
Event 87230
Status
Terminated
Classification
Class II
Quantity
272 tables total (Domestic: 227 tables, Foreign 45 tables)
Official record key
device-enforcement:Z-1149-2021

Official wording

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.

Code information: Model No.: OT1000, OT1100, OT1200

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.