Z-1149-2021 Class II Terminated
FDA device recall Z-1149-2021 was initiated by Steris Corporation on January 21, 2021 and is designated Class II. 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… The recall status is terminated (terminated November 10, 2021). Affected quantity: 272 tables total (Domestic: 227 tables, Foreign 45 tables).
Recall Details
- Product Type
- Devices
- Report Date
- March 3, 2021
- Initiation Date
- January 21, 2021
- Termination Date
- November 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 272 tables total (Domestic: 227 tables, Foreign 45 tables)
Product Description
OT1000 Series Orthopedic Surgical Tables
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 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.
Code Information
Model No.: OT1000, OT1100, OT1200