Recall Z-1986-2019— Clariance Inc
Class III · Terminated
Class III FDA medical device recall by Clariance Inc, initiated 2019-07-01, terminated 2020-07-09. It names one FDA 510(k) clearance: K153326. 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: Potential for the polyaxial screw to become disassembled during implant..
- Recalling firm
- Clariance Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-07-01
- Terminated
- 2020-07-09
- Firm location
- Chicago, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.