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Terminated

Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.

FDA Recall Z-0358-2009 · Posted 2008-12-02

Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeGFA
Date Initiated2008-02-14
Date Terminated2009-07-07
Product Quantity69 total

Reason for Recall

The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.

Firm Action

Consignees were notified via Urgent Medical Device Removal letter dated 2/14/08 to not use the device if it exhibited the problem, provided a response card, and stated that replacement motors will be shipped to the person listed on the returned response card.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela.

Official Source

View FDA Recall →

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

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