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.
What this means for you
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
Related recalls
Same manufacturer · Synthes, Inc.
See all →- ModerateSynthes Recalls MatrixNEURO Screws Due to Incorrect Body Clip Labeling
FDA (Devices) · 2020-08-05
- ModerateSynthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect
FDA (Devices) · 2020-02-05
- ModerateSynthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect
FDA (Devices) · 2020-02-05
- ModerateSynthes Recalls 2.4mm Sterile Locking Screws Due to Packaging Defect
FDA (Devices) · 2020-02-05
- ModerateSynthes 2.4mm Sterile Locking Screw Recall Due to Packaging Defect
FDA (Devices) · 2020-02-05
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02