FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: 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.
- Recall number
- Z-0359-2009
- 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.
- Status
- Terminated
- Initiated
- 2008-02-14
- Posted
- 2008-12-02
- Terminated
- 2009-07-07
- Reason
- 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
- 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
- 69 total
- Distribution
- Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela.
- Lot, serial or model codes
- Serial numbers 1877 through 1925.
- 510(k) numbers
- ["K935391"]
- PMA numbers
- not on file
- Product code
- GFA
- Firm FEI
- 1828100
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28