Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
This recall has been terminated (originally issued February 14, 2017).
- Recall Initiated
- August 20, 2014
- Posted
- February 14, 2017
- Terminated
- February 15, 2017
- Recall Number
- Z-1201-2017
- Quantity
- The total number of distributed devices stands at 260
- Firm Location
- Elkton, MD
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .
Lot / Code Info
Serial Number Range 70194 through 70504
Root Cause
Device Design
Action Taken
Terumo Cardiovascular Systems has contact all affected parties (user facilities and consignees) via a Customer Notification Letter that advises of the recall activity.