Erisma- LP posterior fixation system with the below specifically… — Class III medical device recall Z-1986-2019
Terminated recall by Clariance Inc, reported 2019-07-24, distributed nationwide. Potential for the polyaxial screw to become disassembled during implant.
| Recall number | Z-1986-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Clariance Inc, Chicago, IL, United States |
| Recall initiated | 2019-07-01 |
| Classified | 2019-07-18 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2020-07-09 |
| Distributed | Nationwide (US) |
| Quantity | 4,090 units |
| Model numbers | 01720001, 181510XX, 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 18710024, 18720000 |
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
Reason for recall
Potential for the polyaxial screw to become disassembled during implant.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1986-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.