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BIOPRO, INC.

Last updated September 17, 2026

What BIOPRO, INC. makes

Biopro, Inc. manufactures orthopaedic fixation devices, including non-bioabsorbable bone screws (e.g., cortical and low-head varieties), fixation plates, non-adjustable bone staples, tibial inserts, and orthopaedic reamers. Their portfolio also covers bone wires, trochar wires, and surgical guides like the ACCU-CUT™ Z GUIDE and MTP-FUSION reamer. Some products are reusable, while others are sterile or non-sterile.

The company’s devices fall under FDA Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. Biopro, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Biopro, Inc. manufacture?

Biopro, Inc. specializes in orthopaedic fixation devices. Their product line includes non-bioabsorbable bone screws (such as cortical and low-head screws), fixation plates, non-adjustable bone staples, tibial inserts, and orthopaedic reamers. They also produce bone wires, trochar wires, and surgical guides like the ACCU-CUT™ Z GUIDE and MTP-FUSION reamer. Some devices are reusable, while others are sterile or non-sterile.

Where is Biopro, Inc. based?

Biopro, Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and device distribution, as it operates within the FDA’s jurisdiction.

Which regulatory registries list Biopro, Inc.’s devices?

Biopro, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details.

How are Biopro, Inc.’s devices classified by the FDA?

Biopro, Inc.’s devices are classified under FDA Class I and Class II categories. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. Classification depends on factors like the device’s intended use and potential health impact.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 2929 Lapeer Rd, PORT HURON, MI, 48060
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1832656
DUNS Number: 618749857

Catalogue (3006)

Page 22 of 61

Device	Model / Reference	Registries	Class	Status
L-Shaped Fracture Plate 4 holes, right 2.5/2.8mm Sterile	20719	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 65mm	21286	FDA UDI	Class II	Active
Toe Joint Mpj 2nd5th 13.25mm	16869	FDA UDI	Class II	Active
Shotel Nail System	22839	FDA UDI	Class I	Active
Cortical Screw 3.0mm x 30mm	20814	FDA UDI	Class II	Active
THUMB MOD HEAD 15mm	17007	FDA UDI	Class II	Active
Goez Screw 3.0 X 32mm	18198	FDA UDI	Class II	Active
SCREW D.C. 1.8 x 20mm	17203	FDA UDI	Class II	Active
Fibula Plate 10 Hole, left Sterile	21094	FDA UDI	Class II	Active
Drill Guide 15 18mm	17650	FDA UDI	Class I	Active
Cannulated Drill (6.5)	22277	FDA UDI	Class I	Active
Endo Modular Ceramic Md 43	13015	FDA UDI	Class II	Active
Kwire double trocar 2.0 x 200mm, Sterile	OL20020DS	FDA UDI	Class II	Active
Nut Wrench	22468	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.8mm x 18mm Sterile	20686	FDA UDI	Class II	Active
Head Trial 14MM+4	17615	FDA UDI	Class I	Active
Staple 3 Leg 10x8x12.5	18263	FDA UDI	Class II	Active
Cotton Plate 2mm	20882	FDA UDI	Class II	Active
4.0 x 26mm Go-EZ Screw	18236	FDA UDI	Class II	Active
THUMB MOD HEAD 14mm +4	17507	FDA UDI	Class II	Active
Goez Screw 4.0 X 26mm	18236	FDA UDI	Class II	Active
38mm X 3.0 Hbs Std Ft Pkg	22554	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 11.5 MM	22392	FDA UDI	Class I	Active
Pusher 3 Leg 14x12	18312	FDA UDI	Class I	Active
Memory Staple 30 X 302 X 3 Mm/Lg	17624	FDA UDI	Class II	Active
40mm X 3.0 Hbs Std Ft Pkg	22555	FDA UDI	Class II	Active
Hohman Retractors 6mm	20935	FDA UDI	Class I	Active
3.5 x 8mm Go-EZ Screw	18204	FDA UDI	Class II	Active
5 Mm Bone Screw X 24 Mm	21613	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 40mm sterile	21553	FDA UDI	Class II	Active
2.0 x 34mm Go-EZ Screw	19269	FDA UDI	Class II	Active
Endo Md 53	10186	FDA UDI	Class II	Active
Goez Screw 3.5 X 12mm	18206	FDA UDI	Class II	Active
20mm X 3.0 Hbs Screw Sdst Pkg	20521	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 18mm	21223	FDA UDI	Class II	Active
32mm X 3.0 Hbs Screw Sdst	20332	FDA UDI	Class II	Active
Stem Pc Lg 10	10129	FDA UDI	Class II	Active
Toe Hemi Edge PC LG	19819	FDA UDI	Class II	Active
Insert Uni Lg 6.5	10312	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 10mm Sterile	21004	FDA UDI	Class II	Active
MPJ Trial 21.5mm (ML)	14959	FDA UDI	Class I	Active
13mm HBS® High Compression	18632	FDA UDI	Class II	Active
Goez Screw 2.5 X 34mm	19251	FDA UDI	Class II	Active
6.5 x 65mm Go-EZ Screw	19661	FDA UDI	Class II	Active
Horizon Hybrid Subtalar 12mm	17089	FDA UDI	Class II	Active
Clover Staple 4-Leg Complete kit	19543	FDA UDI	Class I	Active
4.0 x 28mm Go-EZ Screw	18237	FDA UDI	Class II	Active
Memory Staple 25 X 222 X 3mm/Lg	17623	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 75mm	21288	FDA UDI	Class II	Active
Cortical Screw 2.0mm x 8mm	20478	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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Authorities

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FDA Recalls (39)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

BioPro, Inc. has 39 recall records initiated between September 21, 2011, and September 9, 2025, with statuses recorded as open, classified, or terminated. The reasons cited include potential packaging issues compromising sterile barriers, manufacturing flaws in sterile barrier systems, incorrect MR compatibility statements in labeling, and improperly sealed outer packaging for femoral head devices.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Sep 9, 2025	Z-0148-2026	—	open, classified	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.
Sep 9, 2025	Z-0149-2026	—	open, classified	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.
Sep 9, 2025	Z-0151-2026	—	open, classified	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.
Sep 9, 2025	Z-0153-2026	—	open, classified	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.
Sep 9, 2025	Z-0150-2026	—	open, classified	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.
Sep 9, 2025	Z-0152-2026	—	open, classified	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.
Feb 1, 2022	Z-0684-2022	—	terminated	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 MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0683-2022	—	terminated	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 MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0686-2022	—	terminated	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 MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0685-2022	—	terminated	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 MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0688-2022	—	terminated	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 MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0691-2022	—	terminated	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 MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0690-2022	—	terminated	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 MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0687-2022	—	terminated	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 MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0689-2022	—	terminated	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 MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0682-2022	—	terminated	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 MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Jun 25, 2019	Z-2256-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2249-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2253-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2241-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2254-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2243-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2244-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2257-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2252-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2259-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2239-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2250-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2255-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2258-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2248-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2251-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2246-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2242-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2245-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2240-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2247-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Sep 21, 2011	Z-0164-2012	—	terminated	BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
Sep 21, 2011	Z-0163-2012	—	terminated	BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.