—#95639

Product

Sternal Saw II Sterile Blades for the Sarns Sternal Saw System, Catalog number 5589, Terumo Cardiovascular System Corp, Ann Arbor, MI. The sternal saw blades are indicated for use in medial sternotomoties. The saw blades are used wit the Sarns Sternal Saw System.

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: 0505258, 0510335, 0519809, 0524042, 0531107, 0533191, 0536444, 0538524, 0541634, 0545325, 0547867, 0552336, 0561753, 0561751, 0561752, 0557559, 0564337, 0570411, 0571613, 0573009, 0577882, 0581075, 0584965, 0587430, 0585731, 0585730, 0585732, 0598360, 0601970 and 0605113.

Why it was recalled

The firm discovered that some outer box labels contain incorrect information regarding the method of sterilization. The label incorrectly indicates the product was ethylene oxide sterlized but the product actually was sterilzed with gamma radiation.

Root cause (FDA determination)

Labeling design

Action the firm took

Terumo Cardiovascular Systems Corporation firm sent out an 'URGENT MEDICAL DEVICE CORRECTION: SAFETY ADVISORY" letter dated October 20, 2010, to the Director of Cardiac Operating Room Services or Operating Room Nurse Manager.. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the Safety Advisory, assure that all users were aware of the notice, and confirm receipt of the Safety Advisory by faxing the attached Customer Response Form to the fax number on the form. For questions regarding this recall call 1-800-521-2818.

Recalling firm

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

Distribution

Distribution pattern: US, Indonesia, UAE, Hong Kong, Japan, Singapore, Malaysia, Taiwan, Belgium, Uraguay, Venezuela, Columbia, Mexico, Guam, Vietnam and Thailand.

Timeline

Recall initiated: 2010-10-20
Posted by FDA: 2011-01-26
Terminated: 2011-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95639. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.