Steris Corporation Recall 87230
Description: OT1000 Series Orthopedic Surgical Tables
Steris Corporation Recall 87230 Information
Status | Terminated |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1149-2021 |
Event ID | 87230 |
Event Description | OT1000 Series Orthopedic Surgical Tables |
Product Type | Devices |
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. |
Quantity | 272 tables total (Domestic: 227 tables, Foreign 45 tables) |
Recall 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. |
Device Classification | 20210303 |
Device Code Info | Model No.: OT1000, OT1100, OT1200 |
Center Classification Date | 20210224 |
Recall Initiation Date | 20210121 |
Recalling Firm | Steris Corporation |
Initial Notification | Letter |
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