Z-0359-2009

Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI...

Name: Z-0359-2009 Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI...
Creator: Terumo Cardiovascular Systems Corporation
Published: 2008-02-14
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2008-02-14 / Terminated / root cause: manufacturing process

FDA source

Terumo Cardiovascular Systems Corporation began a recall of 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... on 2008-02-14. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0359-2009
Status: Terminated
Initiated: 2008-02-14
Posted: 2008-12-02
Terminated: 2009-07-07
Recalling firm: Terumo Cardiovascular Systems Corporation
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.
Product code: GFA Blade, Saw, General & Plastic Surgery, Surgical
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 69 total
Distribution: Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela.
Product codes and lots: Serial numbers 1877 through 1925.

Product code GFA

K935391Class ISarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk Pack3M Health Care, Sarns / cleared 1994-02-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)