VB Spine nitinol K-wire recalled for potential fracture risk
VB Spine LLC is recalling its blunt nitinol K-wire, catalog number 48280232, used in spinal surgery. The wire may fracture during use, which could delay the procedure and may leave a piece of the broken wire in the patient's bone. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Set aside any affected K-wires from lots 25A459 through 25A526 and do not use them in surgery.
- Check catalog number 48280232 and UDI-DI 07613327096200 against your inventory to find affected units.
- Contact VB Spine LLC about the recall.
- The notice does not specify a remedy such as a replacement or refund; ask VB Spine LLC how to return or replace affected units.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- NITINOL K-WIRE BLUNT; Catalog/Part Number: 48280232; used in spinal surgery
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 12268
- Illnesses reported
- None reported
- Manufactured in
- 505 Park Ave Fl 14, New York, New York, United States
- Classification
- Class II
- Recall number
- Z-0440-2027
In the FDA's words
- Description
- NITINOL K-WIRE BLUNT; Catalog/Part Number: 48280232; used in spinal surgery Potential for the K-wire to fracture during use resulting in procedural delay and possibility of a piece of fractured K-wire remaining in the patient's bone. Catalog/Part Number: 48280232; UDI-DI: 07613327096200; Serial/Lot Number(s) Affected: 25A459, 25A460, 25A461, 25A462, 25A463, 25A464, 25A465, 25A466, 25A467, 25A468, 25A469, 25A470, 25A471, 25A472, 25A473, 25A474, 25A475, 25A476, 25A477, 25A478, 25A479, 25A480, 25A481, 25A482, 25A483, 25A484, 25A485, 25A486, 25A487, 25A488, 25A489, 25A490, 25A491, 25A492, 25A493, 25A494, 25A495, 25A496, 25A497, 25A498, 25A499, 25A500, 25A501, 25A502, 25A503, 25A504, 25A505, 25A506, 25A507, 25A508, 25A509, 25A513, 25A512, 25A514, 25A515, 25A511, 25A510, 25A516, 25A517, 25A518, 25A519, 25A522, 25A525, 25A520, 25A521, 25A523, 25A524, 25A526; Distribution: Domestic: Nationwide Distribution; International: Australia, Belgium, France, Ireland, Italy, Japan, Netherlands, Spain, United Kingdom; Affected quantity: 12268
- Hazard
- Potential for the K-wire to fracture during use resulting in procedural delay and possibility of a piece of fractured K-wire remaining in the patient's bone.