FDA recall Z-1986-2019

Product

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

Reason for recall

Potential for the polyaxial screw to become disassembled during implant.

Distribution

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

Key facts

Status

Terminated

Initiation date

2019-07-01

Report date

2019-07-24

Termination date

2020-07-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1986-2019