Facility

BIOS

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

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

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Product code HSD (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3690
Shoulder Prosthesis, Reverse Configuration
Product code PHX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3660

Recalls & enforcement

Class IITerminated2017-07-13
In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.

FDA inspections (1)

NAI2025-10-20
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by BIOS

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BIOS (FEI 3033273230) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3033273230-bios/

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