Synthes Matrix Mandible Short Threaded Drill Guide Recall for Labeling Error
Synthes, Inc. is recalling 12 units of Matrix Mandible Short Threaded Drill Guides because they have a gray band instead of the green band shown in the guide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a cosmetic labeling discrepancy (band color) with no reported injuries or functional defects, fitting the 'Low' severity criteria for cosmetic defects or packaging-only problems.
Plain-English summary
Synthes, Inc. is recalling 12 units of the Matrix Mandible Short Threaded Drill Guide (part No. 03.503.043, lot #7908431). The product is intended for oral, maxillofacial surgery, trauma, and reconstructive surgery, specifically for fractures of the subcondylar and condylar basis regions of the mandible.
The recall was initiated because the affected units feature a gray colored band instead of the green colored band pictured in the Technique Guide. This discrepancy is a labeling error that does not indicate a functional defect in the device.
The affected units were distributed in the United States to Michigan, Texas, and California. Healthcare facilities and consumers should stop using the affected units and contact Synthes, Inc. for instructions on return or replacement.
The recalled product
- Product
- Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 12
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 No. 03.503.043
- lot #7908431
Distribution
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