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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 6 of 61

Device	Model / Reference	Registries	Class	Status
BioPro	22915	FDA UDI	Class II	Active
Compression Sleeve, Right	22466	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.0mm x 14mm Sterile	20583	FDA UDI	Class II	Active
MVA Cortical Locking screw 2.0mm x 16mm	20475	FDA UDI	Class II	Active
Hbs Screw 2.5 X 38mm Sdst	20514	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 18mm, Sterile	21248	FDA UDI	Class II	Active
Double Drill Guide 2.8-3.0mm	20643	FDA UDI	Class I	Active
SCREW D.C. 1.5 x 50mm	17114	FDA UDI	Class II	Active
TOE NON POROUS COATED MEDIUM SMALL 18.5mm	17033	FDA UDI	Class II	Active
Round Carbide Burr 6.0MM W/ Notch	21691	FDA UDI	Class I	Active
Goez Screw 4.5 X 28mm	18250	FDA UDI	Class II	Active
28mm X 3 Hbs Std Comp - S. C.	19213	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 12.5 MM	22393	FDA UDI	Class I	Active
HEAD FEMORAL 28mm +0	19005	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 45mm	21282	FDA UDI	Class II	Active
Y-Shape Fracture Plate 4 holes 2.5/2.8mm Sterile	20715	FDA UDI	Class II	Active
Cortical Locking Screw, 4.0mm x 38mm	21724	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.0mm x 10mm Sterile	20581	FDA UDI	Class II	Active
2.5 x 24mm HBS Screw	19559	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 26mm	21747	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 2mm, left	20748	FDA UDI	Class II	Active
Pusher 4 Leg 18x16	18301	FDA UDI	Class I	Active
5 Mm Bone Screw X 50 Mm	21422	FDA UDI	Class II	Active
ORIF Standard Calc Plate, short Sterile	21061	FDA UDI	Class II	Active
Goez Screw 3.5 X 50mm	18225	FDA UDI	Class II	Active
Effi+pro Sterilization Tray	20189	FDA UDI	Class I	Active
1/3 Locking Tubular Plate 10 Hole	21185	FDA UDI	Class II	Active
Staple 3 Leg 14x12x10	18068	FDA UDI	Class II	Active
34mm X 3.0 Hbs Std Ft	22584	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 Sizing Probe 10mm	22659	FDA UDI	Class I	Active
Crocodile Reduction Forceps	20931	FDA UDI	Class I	Active
Burr Guide 4 Leg 18x16	18298	FDA UDI	Class I	Active
Insert Total 12x74	15010	FDA UDI	Class II	Active
Dwyer Plate 6mm	20897	FDA UDI	Class II	Active
Lesser Mpj Trial 13.25mm	16970	FDA UDI	Class I	Active
Kwire single trocar 2.5 x 170mm, Sterile	OL17025S	FDA UDI	Class II	Active
2.5 x 16mm HBS Screw	19551	FDA UDI	Class II	Active
Insert Total Mod 10x66	10344	FDA UDI	Class II	Active
Endo Md 45	10182	FDA UDI	Class II	Active
Fibula Plate 3 Hole, right Sterile	21100	FDA UDI	Class II	Active
Staple 3 Leg 14x12x12.5	18069	FDA UDI	Class II	Active
2.5 x 16mm HBS Screw	19551	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 Starter Probe	22650	FDA UDI	Class I	Active
Knee Rt 78	10243	FDA UDI	Class II	Active
Assembly Block	17374	FDA UDI	Class I	Active
Cortical Screw 3.0mm x 12mm	20805	FDA UDI	Class II	Active
9mm Fusion Nail, Left	21406	FDA UDI	Class II	Active
Towel Clamp	18100	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.8mm X 35mm	21523	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 35mm	21280	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.