FDA-Device2018-02-28Class II
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
Synthes, Inc.
Hazard
May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
Sold states
Distribution to US, Canada, and Germany.
Affected count
567 units
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0669-2018Don't want to check this manually?
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