Clariance Erisma-LP Posterior Fixation System Recalled for Screw Disassembly Risk
Clariance Inc is recalling Erisma-LP posterior fixation system components due to a potential for polyaxial screws to disassemble during implantation.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where the defect could cause injury, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
Clariance Inc is recalling the Erisma-LP posterior fixation system, including specific polyaxial screws, screwdrivers, and wrenches. The recall involves 4,090 units distributed nationwide to California, Illinois, Indiana, New York, Ohio, and Texas.
The recall was initiated because of a potential for the polyaxial screws to become disassembled during implantation. This defect could compromise the integrity of the medical device during surgical use.
Healthcare providers and patients who have received these specific devices should contact Clariance Inc or their healthcare provider for instructions on next steps. The affected products include Erisma-LP polyaxial screws in various diameters and lengths, the Erisma-LP Screwdriver, the Erisma-LP T20 Wrench, and the Erisma-LP T20 Snap Fit Tightening Wrench.
The recalled product
- 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…
- Manufacturer
- Clariance Inc
- Affected units
- 4,090
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 1. Catalog Numbers: 181545XX
- 181555XX
- 181565XX
- 181575XX
- 181585XX
- 181595XX
- 181510XX
- 2. Catalog Number 18710024
- 3. Catalog Number 18720000
- 4. Catalog Number 01720001
Distribution
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