Facility
BIOS
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3033273230 |
|---|---|
| Establishment type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | 1295 Nesbit Drive Nesbit, MS, US 38651 |
| Registration status | Active · expires 2026 |
| Parent company | BIOS (owner-operator 10091714) |
| Brand names | Catalyst R1 Reverse Shoulder System |
Devices registered here (2)
- Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedProduct code HSD · Class II · Orthopedic · 21 CFR 888.3690
- Shoulder Prosthesis, Reverse ConfigurationProduct code PHX · Class II · Orthopedic · 21 CFR 888.3660
Recalls & enforcement
- Class IITerminated2017-07-13In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.
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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