The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0001-2013·Announced 2012-10-10

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.

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 2/5 (Moderate).

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…
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

Distributed nationwide across the United States.

The notice also names 14 states specifically:

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