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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 16 of 61

Device	Model / Reference	Registries	Class	Status
5 Mm Bone Screw X 46 Mm	21360	FDA UDI	Class II	Active
Goez Screw 2.5 X 12mm	18175	FDA UDI	Class II	Active
Insert Total Mod 16x78	10371	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 40mm, Sterile	21306	FDA UDI	Class II	Active
Insert Cc 32x55	10077	FDA UDI	Class II	Active
T-Shape Fracture Plate 3 Holes 2mm	21205	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 - 9mm Implant	22645	FDA UDI	Class II	Active
Evans Plate 8mm, right Sterile	21042	FDA UDI	Class II	Active
Drill Bit Sqc 1.5mm 85/18mm	18960	FDA UDI	Class I	Active
Posterior Tibia Plate 4 Hole	21150	FDA UDI	Class II	Active
14mm X 2.5 Hbs Screw Sdst Pkg	20502	FDA UDI	Class II	Active
Mtp Fusion Plate, Narrow 0 Degree, Left	23087	FDA UDI	Class II	Active
16mm HBS® High Compression	18635	FDA UDI	Class II	Active
Drill bit AO QC 2.5 x 110/85mm, Sterile	OL25DBS	FDA UDI	Class I	Active
Dwyer Plate 4mm	20896	FDA UDI	Class II	Active
Quick Connect Trial Handle	19820	FDA UDI	Class I	Active
X-Plate Small	20879	FDA UDI	Class II	Active
Accu-Cut™ 2mm	19507	FDA UDI	Class I	Active
2.5 x 40mm Go-EZ Screw	19254	FDA UDI	Class II	Active
2.5 x 25mm HBS Screw	19560	FDA UDI	Class II	Active
Burr Guide 3 Leg 18x16	18309	FDA UDI	Class I	Active
3.0 x 24mm HBS Screw	19580	FDA UDI	Class II	Active
Calcaneal Plate Module	22933	FDA UDI	Class II	Active
Staple 3 Leg 18x16x15	18073	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 - 10mm Implant	22646	FDA UDI	Class II	Active
3.0 x 26mm HBS Screw	19582	FDA UDI	Class II	Active
25mm HBS® High Compression	18644	FDA UDI	Class II	Active
23mm HBS® High Compression	18642	FDA UDI	Class II	Active
Cortical Locking Screw, 3.5mm x 36mm	21767	FDA UDI	Class II	Active
SMALL STAPLE 11x17x15	17635	FDA UDI	Class II	Active
Stem Trial 8.5MM	17346	FDA UDI	Class I	Active
Cortical Locking Screw 3.5mm x 18mm	20856	FDA UDI	Class II	Active
Insert Total 14x74	15011	FDA UDI	Class II	Active
5 Mm Bone Screw X 44 Mm	21359	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3, 0mm x 24mm Sterile	20782	FDA UDI	Class II	Active
3.5 x 22mm Go-EZ Screw	18211	FDA UDI	Class II	Active
Effi+Pro® Compression/Distraction Kit	20061	FDA UDI	Class I	Active
Drill Guide Single Hole	17656	FDA UDI	Class I	Active
Plantar TMT Plate Right Sterile	21508	FDA UDI	Class II	Active
Osteotome, 15mm	95-1515	FDA UDI	Class I	Active
18mm X 3.0 Hbs Screw Sdst Pkg	20520	FDA UDI	Class II	Active
Medial 4 Column Plate, short, left	20901	FDA UDI	Class II	Active
Small Osteotomes 6mm	20936	FDA UDI	Class I	Active
Goez Screw 4.0 X 44mm	19047	FDA UDI	Class II	Active
Kwire, Double Trocar, 1.1 X 150mm	OL15011DS	FDA UDI	Class II	Active
2.5 x 36mm Go-EZ Screw	19252	FDA UDI	Class II	Active
SMALL STAPLE 13x10	17632	FDA UDI	Class II	Active
Toe Punch	15112	FDA UDI	Class I	Active
Anterior Lateral Tibia Plate 6 Hole, left, Sterile	21160	FDA UDI	Class II	Active
22mm X 2.5 Hbs Std Comp-S.c.	19336	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.