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Class 2 Device Recall OT Surgical Table |
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Date Initiated by Firm |
January 21, 2021 |
Create Date |
February 24, 2021 |
Recall Status1 |
Terminated 3 on November 10, 2021 |
Recall Number |
Z-1149-2021 |
Recall Event ID |
87230 |
Product Classification |
Table, surgical with orthopedic accessories, ac-powered - Product Code JEA
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Product |
OT1000 Series Orthopedic Surgical Tables |
Code Information |
Model No.: OT1000, OT1100, OT1200 |
Recalling Firm/ Manufacturer |
Steris Corporation 5960 Heisley Rd Mentor OH 44060-1834
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For Additional Information Contact |
Michelle LaVan 440-392-8603
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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.
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FDA Determined Cause 2 |
Process control |
Action |
In 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 Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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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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