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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 46 of 61

Device	Model / Reference	Registries	Class	Status
Lesser Mpj Trial 8.75mm	16964	FDA UDI	Class I	Active
3.0 x 23mm HBS Screw	19579	FDA UDI	Class II	Active
Open Wedge Plate 2mm	20629	FDA UDI	Class II	Active
Horizon Titanium Subtalar 11mm	17224	FDA UDI	Class II	Active
Cortical Screw, 3.5mm x 32mm	21733	FDA UDI	Class II	Active
MTP Fusion Plate SM-8 Right	21490	FDA UDI	Class II	Active
Double Drill Guide 3.5-4.0mm Screws	20923	FDA UDI	Class I	Active
SCREW D.C. 1.8 x 30mm	17116	FDA UDI	Class II	Active
Goez Screw 4.0 X 30mm	18238	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 35mm	21544	FDA UDI	Class II	Active
28mm X 2.5 Hbs Std Comp-S.c.	19339	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm x 26mm Sterile	20690	FDA UDI	Class II	Active
2.5 x 30mm HBS Screw	19565	FDA UDI	Class II	Active
Insert Total Mod 10x86	10349	FDA UDI	Class II	Active
Insert Total 8x70	10255	FDA UDI	Class II	Active
Modular Thumb Complete Kit	20066	FDA UDI	Class I	Active
Medial Tibial Plate 14 Hole, right Sterile	21116	FDA UDI	Class II	Active
Staple Positioner 10x8	19512	FDA UDI	Class I	Active
Drill bit AO QC 1.1 x 85/60mm, Sterile	OL11DBS	FDA UDI	Class I	Active
Cortical Screw 2.0mm x 14mm Sterile	20590	FDA UDI	Class II	Active
3.0 x 25mm HBS Screw	19581	FDA UDI	Class II	Active
5 Mm Bone Screw X 40 Mm	21417	FDA UDI	Class II	Active
Lesser Mpj Instrument Tray	14938	FDA UDI	Class I	Active
Cortical Screw, Low Head 3.5mm x 55mm, Sterile	21309	FDA UDI	Class II	Active
Thumb Mod Head Titanium 13mm+2	17799	FDA UDI	Class II	Active
Stem Pc Lg 2	10121	FDA UDI	Class II	Active
Staple 3 Leg 18x16x10	18071	FDA UDI	Class II	Active
5 Mm Bone Screw X 42 Mm	21358	FDA UDI	Class II	Active
HEAD FEMORAL 28mm +3	19006	FDA UDI	Class II	Active
Memory Staple 11 X 81.5 X 1.5mm/Sm	17630	FDA UDI	Class II	Active
5 Mm Bone Screw X 44 Mm	21419	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 45mm, Sterile	21257	FDA UDI	Class II	Active
BioPro Bipolar Head 43mm	18135	FDA UDI	Class II	Active
Memory Staple 15 X 122 X 2mm/Md	17625	FDA UDI	Class II	Active
Accu-Cut™ Two Stage S	16958	FDA UDI	Class I	Active
3.0 x 26mm HBS Screw	19582	FDA UDI	Class II	Active
Cortical Bone Screw 4.5/55mm	16589	FDA UDI	Class II	Active
Kwire double trocar 1.4 x 150mm, Sterile	OL15014DS	FDA UDI	Class II	Active
MTP-FUSION REAMER, concave Ø18mm	20672	FDA UDI	Class I	Active
Goez Screw 4.0 X 10mm	18228	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 65mm	21236	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm x 28mm Sterile	20691	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 26mm	21744	FDA UDI	Class II	Active
5 Mm Bone Screw X 70 Mm	21432	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 28mm Sterile	20703	FDA UDI	Class II	Active
Drill Bit AO QC 2.0mm / 115mm length	20924	FDA UDI	Class I	Active
Insert Providence 10 Deg 32x58	15092	FDA UDI	Class II	Active
Medial Tibia Plate 14 Hole, left Sterile	21128	FDA UDI	Class II	Active
Stem Pc Sh 13	11582	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 12 MM	21707	FDA UDI	Class I	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.