Z-1201-2017 Class II Terminated
FDA device recall Z-1201-2017 was initiated by Terumo Cardiovascular Systems Corporation on Aug 20, 2014 and is designated Class II. 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… The recall status is terminated (terminated Feb 15, 2017). Affected quantity: The total number of distributed devices stands at 260.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 22, 2017
- Initiation Date
- Aug 20, 2014
- Termination Date
- Feb 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- The total number of distributed devices stands at 260
Product Description
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
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 Pattern
Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .
Code Information
Serial Number Range 70194 through 70504
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1201-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026