FDA-Device2012-10-17Class II
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Hazard
Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
Sold states
Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.
Affected count
247 units
Manufactured in
1800 Pyramid Place, N/A, Memphis, TN, United States
Products
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0038-2013Don't want to check this manually?
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