FDA Enforcement
Class III
Terminated
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
Recall: Z-1986-2019
·
Reported July 24, 2019
Enforcement
- Recall Number
- Z-1986-2019
- Event ID
- 83218
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Clariance Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 24, 2019
- Initiation Date
- July 1, 2019
- Classification Date
- July 18, 2019
- Termination Date
- July 9, 2020
- Address
- 4809 N Ravenswood Ave Unit 119, N/A, Chicago, IL, 60640-4417, United States
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
Reason
Potential for the polyaxial screw to become disassembled during implant.
Code Info
1. Catalog Numbers: 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 181510XX; 2. Catalog Number 18710024; 3. Catalog Number 18720000; 4. Catalog Number 01720001
Distribution
Nationwide distribution to CA, IL, IN, NY, OH, TX.
Quantity
4,090 units distributed in the US