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BIOPRO, INC.

Last updated September 17, 2026

Information

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

Catalogue (3006)

Page 7 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Screw 2.5mm x 12mm	20551	FDA UDI	Class II	Active
Hbs Screw 3.0 X 36mm Sdst	20529	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 6 Hole, right, Sterile	21172	FDA UDI	Class II	Active
26mm X 3.0 Hbs Screw Sdst Pkg	20524	FDA UDI	Class II	Active
18mm X 3 Hbs Std Comp - S. C.	19208	FDA UDI	Class II	Active
Knee Lt 86	10222	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 18mm	20808	FDA UDI	Class II	Active
Anterial Lateral Tibia Plate 4 Hole Right	20646	FDA UDI	Class II	Active
18mm X 2.5 Hbs Screw Sdst Pkg	20504	FDA UDI	Class II	Active
Stem Broach 7.5MM	19460	FDA UDI	Class I	Active
Burr Adaptor Mini Microaire	18881	FDA UDI	Class I	Active
K-Wire Threaded Sterile Single Trochar .045	19109	FDA UDI	Class II	Active
Cortical Bone Screw 4.5/40mm	16586	FDA UDI	Class II	Active
9mm Fusion Nail, Right	21409	FDA UDI	Class II	Active
Screw Bone 6.5/45	10729	FDA UDI	Class II	Active
5 Mm Bone Screw X 66 Mm	21430	FDA UDI	Class II	Active
Goez Screw 4.0 X 16mm	18231	FDA UDI	Class II	Active
3.5 x 48mm Go-EZ Screw	18224	FDA UDI	Class II	Active
28mm X 3.0 Hbs Std Ft	22581	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 10mm Sterile	21064	FDA UDI	Class II	Active
Toe Joint Cobalt Chrome Npc Lg 23mm	10062	FDA UDI	Class II	Active
Insert Total 10x78	10264	FDA UDI	Class II	Active
6.5 x 80mm Go-EZ Screw	19664	FDA UDI	Class II	Active
14mm X 3.0 Hbs Screw Sdst Pkg	20518	FDA UDI	Class II	Active
Effi+pro Pin 2.8mm/4.5	20194	FDA UDI	Class I	Active
Toe Porous Coated W/Hole Md	17747	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 40mm sterile	21541	FDA UDI	Class II	Active
5 Mm Bone Screw X 54 Mm	21424	FDA UDI	Class II	Active
HBS Screw Instrument Tray Plus SDST Screws	23019	FDA UDI	Class I	Active
Cortical Locking Screw 4.0mm x 35mm Sterile	21075	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 70mm	21237	FDA UDI	Class II	Active
Straight Fracture Plate 6 Holes 2mm	20604	FDA UDI	Class II	Active
BioPro Bipolar Head 40mm	18132	FDA UDI	Class II	Active
SCREW D.C. 1.8 x 25mm	17204	FDA UDI	Class II	Active
K-Wire with stop 1.2mm	20940	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 9 Hole, Sterile	21144	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 36mm sterile	21551	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 20mm Sterile	20660	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3, 0mm x 26mm Sterile	20783	FDA UDI	Class II	Active
Goez 2.0 6.5 Complete Kit	20045	FDA UDI	Class I	Active
Clover Staple 4 Leg 14 X 12 X 15	18064	FDA UDI	Class II	Active
L-Shaped Fracture Plate 6 holes, left Sterile	20790	FDA UDI	Class II	Active
HEAD FEMORAL 28mm +9	19008	FDA UDI	Class II	Active
Kwire single trocar 2.5 x 310mm, Sterile	OL31025S	FDA UDI	Class II	Active
SCREW D.C. 1.8 x 40mm	17118	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 32mm sterile	21536	FDA UDI	Class II	Active
13mm Fusion Nail, Right	21590	FDA UDI	Class II	Active
Nitinol Guide Wire	21671	FDA UDI	Class II	Active
16mm X 3.0 Hbs Std Ft Pkg	22543	FDA UDI	Class II	Active
4.0 x 14mm Go-EZ Screw	18230	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.