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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 58 of 61

Device	Model / Reference	Registries	Class	Status
Sm Staple 4 3/4 Bulldog Hemo	17651	FDA UDI	Class I	Active
Cortical Locking Screw 3.5mm x 60mm	21319	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 65mm, Sterile	21329	FDA UDI	Class II	Active
Memory Staple 20 X 202 X 3mm/Lg	17622	FDA UDI	Class II	Active
T-Shape Fracture Plate 6 holes 2mm Sterile	20705	FDA UDI	Class II	Active
Toe Joint Cobalt Chrome Npc Md 20mm	10061	FDA UDI	Class II	Active
Straight Fracture Plate 4 holes 2.5/2.8mm	20614	FDA UDI	Class II	Active
Plantar TMT Plate Left	21505	FDA UDI	Class II	Active
3.0 x 12mm HBS Screw	19568	FDA UDI	Class II	Active
5 Mm Bone Screw X 34 Mm	21414	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 14 Hole	21137	FDA UDI	Class II	Active
T-Shape Fracture Plate, 4 Holes Sterile	20945	FDA UDI	Class II	Active
Drill bit with graduations Ø 4.5mm, Sterile	INS003	FDA UDI	Class I	Active
5 Mm Bone Screw X 62 Mm	21428	FDA UDI	Class II	Active
Drill Bit AO QC 2.5mm / 125mm length	20925	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.8mm x 10mm Sterile	20682	FDA UDI	Class II	Active
Goez Screw 3.5 X 22mm	18211	FDA UDI	Class II	Active
Insert Total Mod 13x70	10358	FDA UDI	Class II	Active
5 Mm Bone Screw X 58 Mm	21366	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 12mm	21270	FDA UDI	Class II	Active
Insert Uni Comp Lg 11.5	14142	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 20mm	20836	FDA UDI	Class II	Active
MTP-FUSION REAMER, concave Ø24mm	20674	FDA UDI	Class I	Active
First MPJ Sizer Template SM	22990	FDA UDI	Class I	Unknown
HBS SCREW 3.0 x 28mm S.C. PKG	20422	FDA UDI	Class II	Active
12mm X 3.0 Hbs Std Ft Pkg	22541	FDA UDI	Class II	Active
THUMB MOD HEAD 14mm	17006	FDA UDI	Class II	Active
14mm Nail Cap + 5mm	21630	FDA UDI	Class II	Active
Effi+pro Compression/Distraction Unit	20192	FDA UDI	Class I	Active
Insert Uni Lg 8.5	10313	FDA UDI	Class II	Active
5 Mm Bone Screw X 68 Mm	21431	FDA UDI	Class II	Active
L-Shaped Fracture Plate 4 holes left 2.5/2.8mm	20621	FDA UDI	Class II	Active
TOE NON POROUS COATED SMALL 17mm	10060	FDA UDI	Class II	Active
3.0 x 22mm HBS Screw	19578	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 22mm Sterile	21778	FDA UDI	Class II	Active
Clover Staple 4leg Complete Kit	19543	FDA UDI	Class I	Active
THUMB MOD STEM COBALT TPS 8.5mm	17597	FDA UDI	Class II	Active
Template 12.50mm/13.25mm	16975	FDA UDI	Class I	Active
Hbs Ft Relief Drill 1.2 Sterile	22614	FDA UDI	Class I	Active
Subtalar Instrument Tray	17280	FDA UDI	Class I	Active
ORIF Standard Calc plate, long	20915	FDA UDI	Class II	Active
Endo Modular Ceramic Sh 53	14823	FDA UDI	Class II	Active
Anterial Lateral Tibia Plate 4 Hole Left	20645	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 14mm, Sterile	21296	FDA UDI	Class II	Active
Stem Pc Xshort 1	17042	FDA UDI	Class II	Active
K-Wire with stop 1.6mm	20942	FDA UDI	Class II	Active
Memory Staple 7 X 51.2 X 1.2mm/Xsm	17637	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 36mm	21524	FDA UDI	Class II	Active
Plantar TMT Plate Right	21506	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 95mm, Sterile	21335	FDA UDI	Class II	Active

Related Companies

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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.