FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery.
- Recall number
- Z-0978-2012
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery.
- Status
- Terminated
- Initiated
- 2011-11-17
- Posted
- 2012-02-07
- Terminated
- 2012-12-06
- Reason
- Terumo Cardiovascular Systems has received one report of minute metal shavings leaking from the Sarns Sternal Saw I System at the point where the saw blade is inserted into the saw handpiece.
- Root cause
- Equipment maintenance
- Action
- On 11/16/2011, 11/23/11, 02/3/12, 03/22/12, and 4/24/12 the firm sent a letter entitled "URGENT MEDICAL DEVICE RECALL" to it's domestic direct accounts that included the name of the device, catalog and lot numbers, dates of distribution, and instructions to discontinue use and return the device to the firm for destruction, with a Fax-back response form to be submitted. Medwatch reporting information was also included in the letter. Questions and comments are to be addressed by Customer Service @ 1-800-521-2818, M-F, 8-6 EST
- Quantity
- approx. 10186
- Distribution
- Worldwide Distribution - USA, and the countries of Colombia, Argentina, Lebanon, Belgium, Chile, India, Sri Lanka, Jordan, Egypt, Mexico, Brazil, Taiwan, Honduras, Canada, Germany, Singapore, Republic of Georgia, Hong Kong, Japan, UAE, Philippines, Thailand and South Africa.
- Lot, serial or model codes
- Catalog number 6090, Serial Numbers 0 - 10186
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DWH
- 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