The Recall Desk
HighFDA (Devices)·Z-1986-2019·Announced 2019-07-24

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.

What this means for you

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 Wrenc
Manufacturer
Clariance Inc
Category
Medical Device — Orthopedic Fixation
Hazard
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

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Related recalls

Same hazard · device failure

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