Erisma- LP posterior fixation system with the below recall
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
Why was Erisma- LP posterior fixation system with the below recalled?
Potential for the polyaxial screw to become disassembled during implant.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1. Catalog Numbers: 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 181510XX; 2. Catalog Number 18710024; 3. Catalog Number 18720000; 4. Catalog Number 01720001
- 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
- Recalling firm
- Clariance Inc
- Quantity
- 4,090 units distributed in the US
- Distribution
- Nationwide distribution to CA, IL, IN, NY, OH, TX.
- Recall date
- July 24, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)