—#104231

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.

FDA product code: DWH — Blade, Saw, Surgical, Cardiovascular
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog number 6090, Serial Numbers 0 - 10186

Why it was recalled

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 (FDA determination)

Equipment maintenance

Action the firm took

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

Recalling firm

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

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-11-17
Posted by FDA: 2012-02-07
Terminated: 2012-12-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.