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 Recall Z-0968-2011 · Posted 2011-01-26
Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeGFA
Date Initiated2010-10-20
Date Terminated2011-12-14
Product Quantity42,650 units, 4265 boxes of 10 each
Reason for Recall
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.
Firm Action
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.
Root Cause
Labeling design
Distribution Pattern
US, Indonesia, UAE, Hong Kong, Japan, Singapore, Malaysia, Taiwan, Belgium, Uraguay, Venezuela, Columbia, Mexico, Guam, Vietnam and Thailand.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.