Synthes MIRS Spinal Fixation Devices Recalled for Labeling Correction
Synthes is correcting labeling for MIRS spinal fixation devices to emphasize avoiding rod mis-alignment following reported complaints.
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 source describes a 'Medical Device Labeling Correction' in response to complaints, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls (Score 2). No injuries, deaths, or FDA Class I/USDA Class I designations are mentioned.
Plain-English summary
Synthes USA HQ, Inc. is initiating a Medical Device Labeling Correction for the Minimally Invasive Reduction Screw (MIRS) for MATRIX Spine System. This recall involves 1,602 units of the device, which is intended for percutaneous instrumentation of the thoracolumbar spine. The devices were distributed nationwide, including in California, Florida, Idaho, Indiana, Maryland, Michigan, Montana, Louisiana, New York, Ohio, Pennsylvania, Texas, Virginia, and Washington.
The recall was initiated following a detailed review of the current labeling in response to reported complaints. Synthes identified technique measures and updated the labeling to reflect new technique recommendations. The updated labeling specifically emphasizes the importance of avoiding rod mis-alignment.
This action is a labeling correction rather than a product safety recall for defective hardware. Healthcare providers and facilities that have received these devices should review the updated labeling and follow the new technique recommendations to ensure proper use.
The recalled product
- Product
- MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T
- Manufacturer
- Synthes USA HQ, Inc.
- Category
- Medical Device — Spinal Fixation
- Hazard
- Affected units
- 1,602
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 (1)
- Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A
Distribution
Related recalls
Same manufacturer · Synthes USA HQ, Inc.
See all →- ModerateSynthes Electric Pen Drive Hand Switch Recalled for Labeling Error
FDA (Devices) · 2014-01-08
- ModerateSynthes Trochanteric Fixation Nail Recalled for Incorrect Packaging Labeling
FDA (Devices) · 2013-12-18
- ModerateSynthes TomoFix Osteotomy System Recalled for Surgical Technique Guide Labeling Error
FDA (Devices) · 2013-12-18
- SevereSynthes Recalls Titanium Trochanteric Fixation Nail Systems Due to Missing Bend
FDA (Devices) · 2013-12-11
- ModerateSynthes Soft Tissue Retractor Recalled for Locking Nut Malfunction
FDA (Devices) · 2013-12-11
Same hazard · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02