FDA-Device2015-02-04Class II
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
Synthes, Inc.
Hazard
Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.
Sold states
Worldwide Distribution -- US and Canada.
Affected count
973
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1021-2015Don't want to check this manually?
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