Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel

FDA device recall Z-1201-2017 · posted 2017-02-14 · Terminated

Recall details

Recalling firm

Terumo Cardiovascular Systems Corporation

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.

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.

Root cause

Device Design

Status

Terminated

Product code

MWS

Quantity affected

The total number of distributed devices stands at 260

Distribution

Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .

Date initiated

2014-08-20

Date posted

2017-02-14

Date terminated

2017-02-15

Location

Elkton, MD