Device 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
Z-1986-2019
Product summary
- Firm
- Clariance Inc
- Event
- Event 83218
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4,090 units distributed in the US
- Official record key
device-enforcement:Z-1986-2019
Official wording
Reason: Potential for the polyaxial screw to become disassembled during implant.
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.
Derived failure modes
-
Unknown
Potential for the polyaxial screw to become disassembled during implant.