Class III — Low Risk

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...

Date: July 1, 2019
Company: Clariance Inc
Status: Terminated
Source: FDA (Device)

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.

Affected (51 states)Not affected

About Clariance Inc

Clariance Inc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report