Synthes 2.0 Mandible Locking Plate Bender Recall for Tip Breakage
Synthes, Inc. is recalling 973 units of the 2.0 Mandible Locking Plate Bender/Cutter because the tips may break during use, potentially delaying surgery.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential surgical delay due to device breakage, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Synthes, Inc. is recalling 973 units of the 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143). The device is intended to be used for bending and/or cutting Mandible Locking Plates. The recall covers units distributed in the United States and Canada.
The recall is being conducted because certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If the device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located. The source text does not report any injuries or illnesses associated with this defect.
Healthcare facilities and distributors should stop using the affected units and contact Synthes, Inc. for instructions on return or replacement. The recall includes specific sold and manufacturing lot numbers listed in the agency's official record.
The recalled product
- Product
- 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
- Manufacturer
- Synthes, Inc.
- Affected units
- 973
Distribution
Distribution scope not specified by the agency.
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