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U.S. Department of Health and Human Services

Class 2 Device Recall OT Surgical Table

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 Class 2 Device Recall OT Surgical Tablesee related information
Date Initiated by FirmJanuary 21, 2021
Create DateFebruary 24, 2021
Recall Status1 Terminated 3 on November 10, 2021
Recall NumberZ-1149-2021
Recall Event ID 87230
Product Classification Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
ProductOT1000 Series Orthopedic Surgical Tables
Code Information Model No.: OT1000, OT1100, OT1200
FEI Number 1527821
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information ContactMichelle LaVan
440-392-8603
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionIn 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.
Quantity in Commerce272 tables total (Domestic: 227 tables, Foreign 45 tables)
DistributionDomestic: 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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