Facility

BIOMET MICROFIXATION

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

Key facts

5recalls · worst Class II

3inspections · worst VAI

—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)	1032347
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	1520 Tradeport Dr Jacksonville, FL, US 32218
Registration status	Active · expires 2026
Parent company	BIOMET MICROFIXATION (owner-operator 1032347)
Brand names	SternaLock Blu; SternaLock

Activity by year

Recalls (5)
Inspections (3)

Devices registered here (1)

Plate, Fixation, Bone
Product code HRS (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030

Recalls & enforcement

Class IITerminated2017-04-11
Part of the number on the tray lid differ from the part number on the base.
Class IITerminated2016-06-13
Potential sterility deficiency.
Class IITerminated2015-08-06
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Class IITerminated2014-10-17
Laser etching on the parts is wider and deeper than the conditions previously validated.
Class IITerminated2013-09-20
Product mix occurred prior to final package and labeling process.

FDA inspections (3)

VAI2025-03-04
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2018-05-24
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2017-09-01
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 BIOMET MICROFIXATION

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. “BIOMET MICROFIXATION (FEI 1032347) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1032347-biomet-microfixation/

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