Recall Z-0359-2009 ยท GFA Blade, Saw, General & Plastic Surgery, Surgical
Terumo Cardiovascular Systems Corporation
Terumo Sarns Sternal Saw II System Power Unit, 220/240 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 7084. Note: This product was not sold in the U.S. Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.
| Date | Dec 2, 2008 (initiated Feb 14, 2008) |
| Status | Terminated |
| Reason | The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified via Urgent Medical Device Removal letter dated 2/14/08 to not use the device if it exhibited the problem, provided a response card, and stated that replacement motors will be shipped to the person listed on the returned response card. |
| Quantity | 69 total |
| Distribution | Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela. |
| 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 |