Facility
Incipio Devices SA
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3013223655 |
|---|---|
| Establishment type | Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | Av. des Paquiers 16 St Blaise Neuchatel, CH 2072 |
| Registration status | Active · expires 2026 |
| Parent company | Incipio Devices SA (owner-operator 10089271) |
| Brand names | Straight Reamer Handle; Offset Reamer Handle; Angled Reamer Handle |
Devices registered here (1)
- Orthopedic Manual Surgical InstrumentProduct code LXH · Class I · Orthopedic · 21 CFR 888.4540
Recalls & enforcement
- Class IIOngoing2024-10-30Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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