Facility

BIOVENTUS LLC

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

Key facts

2recalls · worst Class II

—inspections in our data

—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)	3009595577
Establishment type	Repack or Relabel Medical Device
Location	4721 Emperor Blvd Ste 100 Durham, NC, US 27703
Registration status	Active · expires 2026
Parent company	Bioventus LLC (owner-operator 10040666)
Brand names	OsteoMatrix

Activity by year

Recalls (2)

Devices registered here (1)

Filler, Bone Void, Calcium Compound
Product code MQV (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3045

Recalls & enforcement

Class IITerminated2020-12-17
Product may contain white particulates that are microbial in nature.
Class IITerminated2019-02-13
The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.

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. “BIOVENTUS LLC (FEI 3009595577) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009595577-bioventus-llc/

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