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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 11 of 61

Device	Model / Reference	Registries	Class	Status
MVA Cortical Locking Screw, 3.5mm x 36mm	21688	FDA UDI	Class II	Active
TOE JOINT NPC 11.75mm	16822	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 4mm, right Sterile	20956	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 12mm	20794	FDA UDI	Class II	Active
Drill bit AO QC 2.0 x 100/75mm, Sterile	OL20DBS	FDA UDI	Class I	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 14 MM	21709	FDA UDI	Class I	Active
MVA Cortical Locking Screw 3.5mm x 16mm	20818	FDA UDI	Class II	Active
BioPro	22921	FDA UDI	Class II	Active
T-Shape Fracture Plate, 3 Holes	21209	FDA UDI	Class II	Active
Insert Total Mod 13x74	10359	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 85mm	21324	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 10 Hole, left, Sterile	21162	FDA UDI	Class II	Active
Insert Total 12x66	15006	FDA UDI	Class II	Active
MTP Fusion Plate Right Sterile	20707	FDA UDI	Class II	Active
5 Mm Bone Screw X 20 Mm	21601	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 16 Hole	21138	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 7 Hole	21132	FDA UDI	Class II	Active
Goez Screw 2.0 X 40mm	19272	FDA UDI	Class II	Active
40mm X 2.5 Hbs Screw Sdst Pkg	20515	FDA UDI	Class II	Active
Insert Total 16x62	10274	FDA UDI	Class II	Active
Lesser Mpj Trial 14.00mm	16971	FDA UDI	Class I	Active
Dorsal TMT I Fusion Plate 2mm, left Sterile	20949	FDA UDI	Class II	Active
Straight Fracture Plate 4 holes 2.5/2.8mm Sterile	20710	FDA UDI	Class II	Active
Pusher 3 Leg 10x8	18311	FDA UDI	Class I	Active
Sizer 12MM	17189	FDA UDI	Class I	Active
Medial 4 Column Plate, long, right	20902	FDA UDI	Class II	Active
15mm x 2.5 HBS Sd Comp	19356	FDA UDI	Class II	Active
6.5 x 60mm Go-EZ Screw	19660	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 32mm sterile	21560	FDA UDI	Class II	Active
Thumb Tmc Lg 13mm	14270	FDA UDI	Class II	Active
Insert Cc 26 X 53	11798	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 18mm	20561	FDA UDI	Class II	Active
Goez Screw 4.0 X 40mm	19045	FDA UDI	Class II	Active
12mm x 2.5 HBS Sd Comp	19353	FDA UDI	Class II	Active
Goez Screw 2.5 X 22mm	18180	FDA UDI	Class II	Active
BioPro	22917	FDA UDI	Class II	Active
Endo Md 47	10183	FDA UDI	Class II	Active
Endo Modular Ceramic Md 49	13018	FDA UDI	Class II	Active
Endo Modular Ceramic Md 53	14824	FDA UDI	Class II	Active
TOE JOINT NPC 8.75mm W/HOLE	17325	FDA UDI	Class II	Active
12mm X 3.0 Hbs Std Ft	22573	FDA UDI	Class II	Active
Fibula Plate 6 Hole, right	21097	FDA UDI	Class II	Active
Drill Bit AO QC 1.7mm	20648	FDA UDI	Class I	Active
3.0 x 10mm HBS Screw	19566	FDA UDI	Class II	Active
Goez Screw 6.5 X 40mm	19656	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 24mm Sterile	21071	FDA UDI	Class II	Active
T-Shape Fracture Plate 3 Holes 2mm Sterile	21206	FDA UDI	Class II	Active
Insert Total 13x78	10271	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 45mm Sterile	21017	FDA UDI	Class II	Active
Horizon Subtalar Gen II Tray - Prototype	23042	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.