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K2M, Inc recalls Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap
Recalled June 5, 2019 · FDA recall Z-1491-2019 · K2M
Hazard
The products are mislabeled. · FDA Class II
Units
462 total
Sold at
The products were distributed to the following US states: FL, KY, MI, PA, SC, and WV.
Description
The products are mislabeled.
Product
Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared to use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.
Manufacturer(s)
K2M, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →