Clariance Inc: Medical Device Recall in 2019 - (Recall #: Z-1986-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: July 1, 2019

Date Posted: July 24, 2019

Recall Number: Z-1986-2019

Event ID: 83218

Reason for Recall:

Potential for the polyaxial screw to become disassembled during implant.

Status: Terminated

Product Quantity: 4,090 units distributed in the US

Code Information:

1. Catalog Numbers: 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 181510XX; 2. Catalog Number 18710024; 3. Catalog Number 18720000; 4. Catalog Number 01720001

Distribution Pattern:

Nationwide distribution to CA, IL, IN, NY, OH, TX.

Voluntary or Mandated:

Voluntary: Firm initiated