FDA-Device2017-02-22Class II
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Terumo Cardiovascular Systems Corporation
Hazard
Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site.
Sold states
Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .
Affected count
The total number of distributed devices stands at 260
Manufactured in
125 Blue Ball Rd, N/A, Elkton, MD, United States
Products
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1201-2017Don't want to check this manually?
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