Berkeley Advanced Biomaterials
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (2)
Devices registered here (1)
- Filler, Bone Void, Calcium CompoundProduct code MQV (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3045
Recalls & enforcement
- Class IIOngoing2025-09-02Due to incorrect product label (Incorrect product name identified on outer packaging).
FDA inspections (2)
- NAI2019-09-05No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
- NAI2016-04-18No 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.
Related
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. “Berkeley Advanced Biomaterials (FEI 3014298539) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014298539-berkeley-advanced-biomaterials/
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