OT1000 Series Orthopedic Surgical Tables
Reported: March 3, 2021 Initiated: January 21, 2021 #Z-1149-2021
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.
Details
- Recalling Firm
- Steris Corporation
- Units Affected
- 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.
- Location
- Mentor, OH
Frequently Asked Questions
What product was recalled? ▼
OT1000 Series Orthopedic Surgical Tables. Recalled by Steris Corporation. Units affected: 272 tables total (Domestic: 227 tables, Foreign 45 tables).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 3, 2021. Severity: Moderate. Recall number: Z-1149-2021.
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