FDA-Device2012-10-17Class II
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, 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.
Medtronic Sofamor Danek USA Inc
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
1014 units
Manufactured in
1800 Pyramid Place, N/A, Memphis, TN, United States
Products
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, 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-0037-2013Don't want to check this manually?
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