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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 55 of 61

Device	Model / Reference	Registries	Class	Status
Drill Guide 15 - 18MM	17650	FDA UDI	Class I	Active
2.5 x 30mm HBS Screw	19565	FDA UDI	Class II	Active
2.5 x 27mm HBS Screw	19562	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 2mm, right Sterile	20954	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 14mm	20488	FDA UDI	Class II	Active
25mm x 2.5 HBS Sd Comp	19366	FDA UDI	Class II	Active
18mm HBS® High Compression	18637	FDA UDI	Class II	Active
XSMALL STAPLE 9x7	17638	FDA UDI	Class II	Active
3.0 x 8mm Go-EZ Screw	18186	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3, 0mm x 16mm Sterile	20778	FDA UDI	Class II	Active
15mm Fusion Nail, Left	21588	FDA UDI	Class II	Active
4.5 x 6mm Go-EZ Screw	18239	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 24mm sterile	21776	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 10 MM	21695	FDA UDI	Class I	Active
Rectangular Plate S	20885	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3, 0mm x 14mm Sterile	20777	FDA UDI	Class II	Active
Mod Thumb Oscillating Burr Coarse	17343	FDA UDI	Class I	Active
K-Wire Threaded Sterile Single Trochar .062	19111	FDA UDI	Class II	Active
HEAD FEMORAL CERAMIC 28mm +0	19024	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 14 Hole, Sterile	21147	FDA UDI	Class II	Active
HBS SCREW 3.0 x 20mm S.C. PKG	20418	FDA UDI	Class II	Active
MPJ Trial 23mm (LG)	12237	FDA UDI	Class I	Active
Insert Total Mod 20x62	10374	FDA UDI	Class II	Active
Insert Total 10x86	10266	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 8 Hole, Sterile	21193	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 24mm Sterile	20701	FDA UDI	Class II	Active
Insert Total 8x82	10258	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 75mm	21322	FDA UDI	Class II	Active
Template11.0mm/11.75mm	16974	FDA UDI	Class I	Active
MVA Cortical Locking Screw 3.0mm x 22mm	20799	FDA UDI	Class II	Active
Drill Bit, Ao Qc, 2.5mm	OL25DB	FDA UDI	Class I	Active
2.5 x 12mm HBS Screw	19547	FDA UDI	Class II	Active
13mm HBS® Standard Compression	18611	FDA UDI	Class II	Active
Osteotome, Bone Cement, Bevelled, 310mm X 10mm	95-7554	FDA UDI	Class I	Active
Staple 4 Leg 10x8x12.5	18260	FDA UDI	Class II	Active
Kwick-Wire Screw 3.0mm	20040	FDA UDI	Class II	Active
ORIF Calc Plate, short	20910	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.0mm x 12mm Sterile	20582	FDA UDI	Class II	Active
Locking Drill Guide 2.0mm	20636	FDA UDI	Class I	Active
Goez Screw 6.5 X 65mm	19661	FDA UDI	Class II	Active
2.0 x 16mm Go-EZ Screw	18167	FDA UDI	Class II	Active
4.5 x 46mm Go-EZ Screw	19038	FDA UDI	Class II	Active
4.0 x 10mm Go-EZ Screw	18228	FDA UDI	Class II	Active
Impactor Tip Flat	18284	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.8mm x 30mm Sterile	20692	FDA UDI	Class II	Active
TSplitter, 10MM x 310MM	95-7541	FDA UDI	Class I	Active
5 Mm Bone Screw X 60 Mm	21367	FDA UDI	Class II	Active
Goez Screw 4.0 X 28mm	18237	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 Sizing Probe 6mm	22655	FDA UDI	Class I	Active
Hbs Ft Relief Drill 1.0 Sterile	22613	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.