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Terumo Cardiovascular Systems Corporation recalls Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Recalled February 22, 2017 · FDA recall Z-1201-2017 · Terumo Cardiovascular Systems
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. · FDA Class II
Units
The total number of distributed devices stands at 260
Sold at
Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .
Description
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.
Product
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Manufacturer(s)
Terumo Cardiovascular Systems Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →