The Recall Desk
ModerateFDA (Devices)·Z-1781-2014·Announced 2014-06-18

Synthes Mandible Plate Cutter Recalled for Potential Corrosion

Synthes, Inc. is recalling 14 units of the Matrix Mandible Short Cut Plate Cutter due to potential discoloration and corroded material on the tool's face.

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, but the source text describes a potential material defect (discoloration/corrosion) without reporting any specific injuries, illnesses, or hospitalizations. This aligns with a moderate severity rating for a precautionary recall of a medical device where the risk is theoretical or low-risk contamination.

Plain-English summary

Synthes, Inc. is recalling 14 units of the Synthes Matrix Mandible Short Cut Plate Cutter. The product is intended for use in oral and maxillofacial surgery. The recall was initiated after the manufacturer discovered internally that the face of the cutter in the affected lot has the potential for discoloration or corroded material.

The affected product is identified by part number 03.503.057 and lot number 8453237. The units were distributed in the United States, specifically in the states of California, Connecticut, Florida, Georgia, New York, South Dakota, and Texas.

Healthcare providers and facilities that have received this product should stop using it immediately. They should contact Synthes, Inc. for further instructions on how to return or dispose of the affected units.

The recalled product

Product
Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
Manufacturer
Synthes, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
14

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • part number: 03.503.057
  • lot number 8453237

Distribution

Distributed in 7 states:

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