Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Erisma- LP posterior fixation system with the below specifically affected Recalled by Clariance Inc Due to Potential for the polyaxial screw to become disassembled...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Clariance Inc directly.
Affected Products
Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench
Quantity: 4,090 units distributed in the US
Why Was This Recalled?
Potential for the polyaxial screw to become disassembled during implant.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Clariance Inc
Clariance Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report