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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 50 of 61

Device	Model / Reference	Registries	Class	Status
6.5 x 75mm Go-EZ Screw	19663	FDA UDI	Class II	Active
BioPro	20970	FDA UDI	Class II	Active
5 Mm Bone Screw X 64 Mm	21369	FDA UDI	Class II	Active
Depth Gauge 6.5	19730	FDA UDI	Class I	Active
HEAD FEMORAL 36mm +6	19056	FDA UDI	Class II	Active
5 Mm Bone Screw X 64 Mm	21429	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 32mm sterile	21548	FDA UDI	Class II	Active
Wrench	18929	FDA UDI	Class I	Active
Fibula Plate 10 Hole, left	21089	FDA UDI	Class II	Active
Effi+pro Pin 2.5mm Coil	20198	FDA UDI	Class I	Active
Clover Staple 3 Leg 10 X 8 X 15	18264	FDA UDI	Class II	Active
Kwire double trocar 1.0 x 230mm, Sterile	OL23010DS	FDA UDI	Class II	Active
Medial 3 Column Plate, long, left	20907	FDA UDI	Class II	Active
Kwire, Double Trocar, 1.6 X 150mm	OL15016DS	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 22mm	21275	FDA UDI	Class II	Active
Cloverleaf Plate 4 holes 2.5/2.8mm	20627	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3.5mm x 32mm Sterile	21682	FDA UDI	Class II	Active
4.5 x 28mm Go-EZ Screw	18250	FDA UDI	Class II	Active
Insert Total Mod 20x74	10377	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 30mm	20803	FDA UDI	Class II	Active
2.0 x 48mm Go-EZ Screw	19276	FDA UDI	Class II	Active
22mm x 3 HBS High Comp - S. C.	19195	FDA UDI	Class II	Active
Insert Total 14x82	15015	FDA UDI	Class II	Active
Towel Clamp	18100	FDA UDI	Class I	Active
Insert Providence 28x56	15130	FDA UDI	Class II	Active
MTP Fusion Plate MD-8 Left Sterile	21502	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 24mm Sterile	21779	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 13 MM	21698	FDA UDI	Class I	Active
Evans Plate 4mm, left	20888	FDA UDI	Class II	Active
2.5 x 13mm HBS Screw	19548	FDA UDI	Class II	Active
Shotel Nail System	22840	FDA UDI	Class I	Active
T-Shape Fracture Plate, 6 Holes	20878	FDA UDI	Class II	Active
Alignment Guide W/ Pin	19802	FDA UDI	Class I	Active
MVA Cortical Locking Screw, 3.5mm x 38mm Sterile	21685	FDA UDI	Class II	Active
Drill Sleeve	21658	FDA UDI	Class I	Active
Cortical Locking Screw 4.0mm x 65mm	20848	FDA UDI	Class II	Active
Cannulated Drill Sterile 3.0-3.5MM	19235	FDA UDI	Class I	Active
32mm X 3.0 Hbs Std Ft	22583	FDA UDI	Class II	Active
4.0 x 42mm Go-EZ Screw	19046	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 16mm	20855	FDA UDI	Class II	Active
Evans Plate 6mm, right	20893	FDA UDI	Class II	Active
4.0 x 8mm Go-EZ Screw	18227	FDA UDI	Class II	Active
Clover Staple 4 Leg 14 X 12 X 12.5	18063	FDA UDI	Class II	Active
Evans Plate 8mm, left	20890	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 8.5 MM	22385	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.8mm X 35mm sterile	21538	FDA UDI	Class II	Active
Open Wedge Plate 5mm Sterile	20728	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 20mm	20809	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 8mm	20485	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 22mm	20821	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.