Facility

Brasseler U.S.A. Medical, LLC

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)	3004949275
Establishment type	Repack or Relabel Medical Device
Location	1 Brasseler Blvd Savannah, GA, US 31419
Registration status	Active · expires 2026
Parent company	Brasseler U.S.A. Medical, LLC (owner-operator 9010748)
Brand names	Axiom Slap Hammer

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

System, Cement Removal Extraction
Product code LZV (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.4580

Recalls & enforcement

Class IITerminated2022-01-28
One lot of product was distributed in unsealed packaging

FDA inspections (1)

NAI2019-05-21
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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 Brasseler U.S.A. Medical, LLC

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. “Brasseler U.S.A. Medical, LLC (FEI 3004949275) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004949275-brasseler-u-s-a-medical-llc/

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