Recall Z-1986-2019 ยท NKB Thoracolumbosacral Pedicle Screw System
Clariance Inc
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
| Date | Jul 1, 2019 |
| Status | Terminated |
| Reason | Potential for the polyaxial screw to become disassembled during implant. |
| Root cause | Use error |
| Action | Clariance, Inc. notified customers on about 07/01/2019 via "MEDICAL DEVICE FIELD SAFETY NOTICE - SN20190603". Customers were informed that when using the 18710024 Screwdriver, the user should ensure that the tip of the screwdriver is properly engaged into the receiving Torx bore of the Erisma-LP polyaxial screw. After proper engagement, the user is able to fully connect the screwdriver on the screw head. Disassembly of the polyaxial screw can occur when the 18710024 Screwdriver is not fully inserted and threaded into the screw head. Additionally when using the 18720000T20 Wrench or 0172000 |
| Quantity | 4,090 units distributed in the US |
| Distribution | Nationwide distribution to CA, IL, IN, NY, OH, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153326 | Erisma-LP Spinal Fixation System Clariance, Sas, Mar 8, 2016 |