Z-1986-2019 Class III Terminated
FDA device recall Z-1986-2019 was initiated by Clariance Inc on July 1, 2019 and is designated Class III. Reason for recall: Potential for the polyaxial screw to become disassembled during implant. The recall status is terminated (terminated July 9, 2020). Affected quantity: 4,090 units distributed in the US.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- July 1, 2019
- Termination Date
- July 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,090 units distributed in the US
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
Reason for Recall
Potential for the polyaxial screw to become disassembled during implant.
Distribution Pattern
Nationwide distribution to CA, IL, IN, NY, OH, TX.
Code Information
1. Catalog Numbers: 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 181510XX; 2. Catalog Number 18710024; 3. Catalog Number 18720000; 4. Catalog Number 01720001