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Terminated

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

FDA Recall Z-1201-2017 · Posted 2017-02-14

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeMWS
Date Initiated2014-08-20
Date Terminated2017-02-15
Product QuantityThe total number of distributed devices stands at 260

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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