MIRS for MATRIX Spine System. Minimally Invasive recall: Labeling Error
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS…
Why was MIRS for MATRIX Spine System. Minimally Invasive recalled?
Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling associated with this system. The labeling reflects updated technique recommendations and emphasizes the importance of avoiding rod mis-alignment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A
- Product
- MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS…
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 1602
- Distribution
- Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA.
- Recall date
- October 10, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)