VB Spine has recalled 12,268 Nitinol K-wire blunt devices used in spinal surgery because they could fracture during procedures, potentially leaving fragments in patients’ bones.
The FDA classified the recall as Class II and posted it Nov. 12. The affected devices are part of the company’s ES2 Spinal System, according to the agency’s recall database.
The company initiated the recall Oct. 2 over concerns that the wires could break during use and delay procedures. The FDA identified process control as the cause.
VB Spine sent urgent recall letters to customers Oct. 2. The letters direct facilities to inspect their inventory and complete a business reply form, even if they find no affected product. VB Spine sales representatives will coordinate retrieval and removal of any affected devices.
The recalled wires are catalog number 48280232, lots 25A459 through 25A526.
The devices were distributed nationwide and in nine other countries, including Australia, France, Japan and the United Kingdom. The recall remains open.
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