Class III — Clariance Inc
| Recalling firm | CLARIANCE-SAS |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Potential for the polyaxial screw to become disassembled during implant. |
| 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 |
| Quantity | 4,090 units distributed in the US |
| Distribution | Nationwide distribution to CA, IL, IN, NY, OH, TX. |
| Initiated | 2019-07-01 |
| Classified | 2019-07-18 |
| Terminated | 2020-07-09 |
| Recall number | Z-1986-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Clariance Inc (Z-1986-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83218/
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