Facility

BIOPRO, INC.

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

Key facts

3recalls · 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)	1832656
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	2929 Lapeer Rd PORT HURON, MI, US 48060
Registration status	Active · expires 2026
Parent company	BIOPRO, INC. (owner-operator 9001497)
Brand names	Femur Plate Template

Activity by year

Recalls (3)

Devices registered here (1)

Template
Product code HWT (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4800

Recalls & enforcement

Class IIOngoing2025-09-09
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Class IITerminated2022-02-01
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is M…
Class IITerminated2019-06-25
Manufacturing flaw in the sterile barrier system

All facilities operated by BIOPRO, INC.

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. “BIOPRO, INC. (FEI 1832656) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1832656-biopro-inc/

Not open yet

Alerts for BIOPRO, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.