—#67167

Product

Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 7084. Note: This product was not sold in the U.S. 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 product code: GFA — Blade, Saw, General & Plastic Surgery, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K935391
Affected lot / code info: Serial numbers 1877 through 1925.

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Terumo Cardiovascular Systems Corporation
Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9586

Distribution

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

Timeline

Recall initiated: 2008-02-14
Posted by FDA: 2008-12-02
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67167. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.