FDA-Device2013-03-20Class II
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
Synthes USA HQ, Inc.
Hazard
Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
Sold states
Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.
Affected count
18
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0938-2013Don't want to check this manually?
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