Recall Z-0968-2011 ยท GFA Blade, Saw, General & Plastic Surgery, Surgical
Terumo Cardiovascular Systems Corporation
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.
| Date | Jan 26, 2011 (initiated Oct 20, 2010) |
| Status | Terminated |
| Reason | 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 | Labeling design |
| 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- |
| Quantity | 42,650 units, 4265 boxes of 10 each |
| Distribution | US, Indonesia, UAE, Hong Kong, Japan, Singapore, Malaysia, Taiwan, Belgium, Uraguay, Venezuela, Columbia, Mexico, Guam, Vietnam and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935391 | SARNS STERNAL SAW II, STERNAL SAW II BLADE, SARNS SAW BLADES-NON-STERILE BULK PACK 3M Health Care, Sarns, Feb 24, 1994 |