Reported Jul 24, 2019 · Terminated
Erisma- LP posterior fixation system with the below specifically affected products
Clariance Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Clariance Inc · 4809 N Ravenswood Ave Unit 119 · Chicago, IL · 60640-4417
Is this the product you have?
Erisma- LP posterior fixation system with the below specifically affected products
4 of 4 products
| # | Product as published |
|---|---|
| 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 |
- Lot codes and dates
- 1
- Catalog Numbers
181545XX181555XX181565XX181575XX181585XX181595XX181510XX2. Catalog Number 187100243. Catalog Number 187200004. Catalog Number 01720001
- Amount recalled
- 4,090 units distributed in the US
Where it was sold
Why it was recalled
Potential for the polyaxial screw to become disassembled during implant.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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