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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 24 of 61

Device	Model / Reference	Registries	Class	Status
Screw Pick Up 1.5 2.7	18334	FDA UDI	Class I	Active
Goez Screw 3.5 X 6mm	18203	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 11.5 MM	22391	FDA UDI	Class I	Active
Cotton Plate 2mm Sterile	20961	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 55mm	21284	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 18mm Sterile	21068	FDA UDI	Class II	Active
K-Wire Hbs Sterile	19688	FDA UDI	Class II	Active
Toe Joint Mpj 2nd5th 12.50mm	16868	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 20mm	21741	FDA UDI	Class II	Active
12mm Nail Cap + 5mm	21639	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 50mm	20829	FDA UDI	Class II	Active
MTP Fusion Plate Left	20610	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 20mm	21224	FDA UDI	Class II	Active
Insert Cc 28x50	10066	FDA UDI	Class II	Active
23mm x 2.5 HBS Sd Comp	19364	FDA UDI	Class II	Active
Toe Non Porous Coated W/Hole Lg	17744	FDA UDI	Class II	Active
Implant Screw System Sterilization Tray	21714	FDA UDI	Class I	Active
First MPJ Sizer Template ML	22993	FDA UDI	Class I	Unknown
Toe Joint Titanium Pc Sm 17mm	17035	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 22mm	21225	FDA UDI	Class II	Active
36mm X 3.0 Hbs Screw Sdst	20334	FDA UDI	Class II	Active
5 Mm Bone Screw X 72 Mm	21606	FDA UDI	Class II	Active
5 Mm Bone Screw X 52 Mm	21363	FDA UDI	Class II	Active
TMT I Medial Fusion Plate	20634	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 16mm	20553	FDA UDI	Class II	Active
MVA Cortical Locking screw 2.0mm x 10mm	20472	FDA UDI	Class II	Active
Y-shape Fracture Plate 6 holes 2mm	20607	FDA UDI	Class II	Active
5 Mm Bone Screw X 80 Mm	21610	FDA UDI	Class II	Active
Depth Gauge 2.0 3.0	19735	FDA UDI	Class I	Active
Osteotome, Bone Cement, Bevelled, 310mm X 7mm	95-7555	FDA UDI	Class I	Active
BioPro Bipolar Head 51mm	18143	FDA UDI	Class II	Active
Kwire Sterile 2mm X 170mm 6.5mm Screw	19871	FDA UDI	Class II	Active
Fasciotome	19494	FDA UDI	Class I	Active
BioPro Bipolar Head 38mm	18130	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 8mm Sterile	20594	FDA UDI	Class II	Active
26mm X 3 Hbs Std Comp - S. C.	19212	FDA UDI	Class II	Active
Knee Rt 62	10239	FDA UDI	Class II	Active
Hbs Screw 2.5 X 14mm Sdst	20502	FDA UDI	Class II	Active
15mm Fusion Nail, Right	21600	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 36mm sterile	21539	FDA UDI	Class II	Active
Rod Tibial Medullary 11x150	10351	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 70mm, Sterile	21330	FDA UDI	Class II	Active
K-Wire Sterile Single Trochar .035	19106	FDA UDI	Class II	Active
THUMB MOD STEM 10.0mm	17243	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3, 0mm x 20mm Sterile	20780	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 12mm	20832	FDA UDI	Class II	Active
5 Mm Bone Screw X 74 Mm	21617	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 24mm	20564	FDA UDI	Class II	Active
Drill Guide 3 Leg 10x8	18302	FDA UDI	Class I	Active
Cortical Screw 2.8mm X 32 mm	21509	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.