CLASS III Device recall · Reported 24 Jul 2019 · FDA Enforcement Report
Erisma- LP posterior fixation system recalled by Clariance
Clariance is recalling Erisma- LP posterior fixation system with the below specifically products: Erisma-LP, distributed nationwide in the US. The recall was initiated on 1 Jul 2019 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1986-2019
- FDA event ID
- 83218
- Recalling firm
- Clariance, Chicago, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Jul 2019
- FDA classified
- 18 Jul 2019
- Reported
- 24 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 1 Jul 2019 | Recall initiated by company | |
| 18 Jul 2019 | Classified by FDA | +17 days |
| 24 Jul 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the polyaxial screw to become disassembled during implant.
Product as listed by the FDA
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
Where it was distributed
Nationwide distribution to CA, IL, IN, NY, OH, TX.
Questions about this recall
Is Erisma- LP posterior fixation system with the below specifically products: Erisma-LP recalled?
Yes. Clariance recalled Erisma- LP posterior fixation system with the below specifically products: Erisma-LP on 1 Jul 2019. The recall is Class III and its status is Terminated. Recall number Z-1986-2019.
Why was it recalled?
Potential for the polyaxial screw to become disassembled during implant.
Which lots are affected?
1. Catalog Numbers: 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 181510XX; 2. Catalog Number 18710024; 3. Catalog Number 18720000; 4. Catalog Number 01720001
Where was it sold?
Nationwide distribution to CA, IL, IN, NY, OH, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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