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BIOPRO, INC.

Last updated September 17, 2026

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 25 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Screw 3.5mm x 30mm, Sterile	21254	FDA UDI	Class II	Active
Fibula Plate 6 Hole, left Sterile	21092	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 85mm, Sterile	21315	FDA UDI	Class II	Active
Insert Providence 10 Deg 32x60	15093	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 16mm	20560	FDA UDI	Class II	Active
Cloverleaf Plate 3 holes 2.5/2.8mm Sterile	20722	FDA UDI	Class II	Active
22mm HBS® Standard Compression	18620	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 10mm	21269	FDA UDI	Class II	Active
Goez Screw 4.5 X 10mm	18241	FDA UDI	Class II	Active
Drill Guide Locking Bolt	21654	FDA UDI	Class I	Active
Rod Tibial Medullary 9x150	10340	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 16mm	20807	FDA UDI	Class II	Active
SCREW D.C. 1.5 x 40mm	17112	FDA UDI	Class II	Active
BioPro	22798	FDA UDI	Class II	Active
Rod Tibial Medullary 15x50	10365	FDA UDI	Class II	Active
MEDIUM STAPLE 20x20	17627	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 90mm, Sterile	21216	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 65mm Sterile	21081	FDA UDI	Class II	Active
First MPJ Sizer Template MD	22992	FDA UDI	Class I	Unknown
15mm Fusion Nail, Right	21592	FDA UDI	Class II	Active
Goez Screw 4.5 X 48mm	19039	FDA UDI	Class II	Active
Goez Screw 3.5 X 20mm	18210	FDA UDI	Class II	Active
2.5 x 14mm HBS Screw	19549	FDA UDI	Class II	Active
Goez Screw 2.0 X 10mm	18164	FDA UDI	Class II	Active
22mm X 3 Hbs Std Comp - S. C.	19210	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 40mm Sterile	21076	FDA UDI	Class II	Active
Head Femoral 28 Md Lt	14090	FDA UDI	Class II	Active
Clover Staple 4 Leg 10mm x 8mm x 15mm	18261	FDA UDI	Class II	Active
SCREW D.C. 1.8 x 55mm	17121	FDA UDI	Class II	Active
10mm Fusion Nail, Left	21407	FDA UDI	Class II	Active
Medial Tibial Plate 10 Hole, right Sterile	21114	FDA UDI	Class II	Active
Insert Total 20x70	10283	FDA UDI	Class II	Active
Insert Uni Comp Sm 8.5	14134	FDA UDI	Class II	Active
Xsmall Staple Drill Bit 1.4mm	17659	FDA UDI	Class I	Active
Anterior Lateral Tibia Plate 6 Hole, right	21166	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 90mm	21291	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 20mm	20562	FDA UDI	Class II	Active
Cortical Screw 2.0mm x 14mm	20481	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 5 Hole, Sterile	21190	FDA UDI	Class II	Active
1.6x310mm Single Trocar	OL31016S	FDA UDI	Class II	Active
Tara Femoral Component 41	10086	FDA UDI	Class II	Active
Knee Lt 62	10216	FDA UDI	Class II	Active
Kwire, Single Trocar, 1.6 X 150mm	OL15016S	FDA UDI	Class II	Active
9mm Nail Cap	21379	FDA UDI	Class II	Active
HEAD FEMORAL 32mm +9	19135	FDA UDI	Class II	Active
Trial 9MM	17191	FDA UDI	Class I	Active
Kwire double trocar 1.6 x 250mm, Sterile	OL25016DS	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 20mm Sterile	20998	FDA UDI	Class II	Active
Insert Cc 28x60	10070	FDA UDI	Class II	Active
TOE JOINT NPC 9.5mm W/HOLE	17326	FDA UDI	Class II	Active

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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.

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.