Synthes Matrix Coronal Bender Recall Due to Tip Breakage
Synthes USA is recalling 209 Matrix 5.5mm Coronal Benders because tips broke during use. The devices are used for spinal stabilization.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where a functional failure (tip breakage) occurred, but the source text does not report any injuries or illnesses.
Plain-English summary
Synthes USA HQ, Inc. is recalling 209 units of the Synthes Matrix 5.5.mm Left and Right Coronal Bender. These medical devices are used to bend spinal rods for the stabilization of the thoracic, lumbar, sacral, and/or iliac spine.
The recall was initiated after a complaint was received regarding the tips of the benders breaking while a spinal rod component was being bent. The affected products include parts 03.632.040 and 03.632.041 with various lot numbers.
The recalled devices were distributed nationwide in the United States, including in Georgia, Florida, California, Utah, Iowa, Arizona, and Ohio, as well as internationally to Canada. Healthcare facilities should stop using these devices and contact Synthes USA for further instructions.
The recalled product
- Product
- Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine throug
- Manufacturer
- Synthes USA HQ, Inc.
- Category
- Medical Device — Spinal Fixation
- Hazard
- Affected units
- 209
Distribution
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