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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 41 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Screw 2.5mm x 18mm	20554	FDA UDI	Class II	Active
Goez Screw 3.5 X 38mm	18219	FDA UDI	Class II	Active
Goez Screw 2.5 X 48mm	19258	FDA UDI	Class II	Active
Medial Tibia Plate 10 Hole, left	21120	FDA UDI	Class II	Active
HEMI EDGE™ TOE MEDIUM SMALL 18.5mm	19539	FDA UDI	Class II	Active
2.5 x 29mm HBS Screw	19564	FDA UDI	Class II	Active
Anchor Pin	17647	FDA UDI	Class II	Active
Kwire single trocar 2.5 x 150mm, Sterile	OL15025S	FDA UDI	Class II	Active
4.0 x 46mm Go-EZ Screw	19048	FDA UDI	Class II	Active
Head Femoral 28 Sh Lt	14089	FDA UDI	Class II	Active
Medial Tibial Plate 14 Hole, right	21110	FDA UDI	Class II	Active
T-Shape Fracture Plate 4 holes 2mm Sterile	20668	FDA UDI	Class II	Active
18mm HBS® Standard Compression	18616	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 20mm, Sterile	21299	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 16mm	20489	FDA UDI	Class II	Active
TOE JOINT NPC 11.0mm	16821	FDA UDI	Class II	Active
Insert Cc 32x69	10083	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 85mm, Sterile	21265	FDA UDI	Class II	Active
Knee Lt 70	10218	FDA UDI	Class II	Active
Medial 4 Column Plate, short, left Sterile	21049	FDA UDI	Class II	Active
5" Pointed Bone Clamp	18338	FDA UDI	Class I	Active
Cortical Locking Screw, 4.0mm x 36mm	21723	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 34mm sterile	21561	FDA UDI	Class II	Active
Thumb Tmc Lg 14.5mm	14271	FDA UDI	Class II	Active
5 Mm Bone Screw X 28 Mm	21605	FDA UDI	Class II	Active
Toe Porous Coated W/Hole Sm	17745	FDA UDI	Class II	Active
Kwire Sterile Single Trochar .062	19110	FDA UDI	Class II	Active
Allen Key	18921	FDA UDI	Class I	Active
2.5 x 26mm HBS Screw	19561	FDA UDI	Class II	Active
HBS SCREW 2.5 x 14mm S.C. PKG	20399	FDA UDI	Class II	Active
Drill Guide 3 Leg 14x12	18303	FDA UDI	Class I	Active
Hbs Ft Relief Drill 1.2	22523	FDA UDI	Class I	Active
T25 Screw Driver	21662	FDA UDI	Class I	Active
5 Mm Bone Screw X 38 Mm	21416	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 12mm Sterile	21065	FDA UDI	Class II	Active
Toe Joint Titanium Pc M/S 18.5mm	17197	FDA UDI	Class II	Active
Insert Cc 32x60	10079	FDA UDI	Class II	Active
Insert Total 20x82	10286	FDA UDI	Class II	Active
Insert Cc 26 X 60	11801	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 16 MM	21701	FDA UDI	Class I	Active
ACCU-CUT™ 3mm OFFSET	17300	FDA UDI	Class I	Active
ORIF Calc Plate, long Sterile	21060	FDA UDI	Class II	Active
Head Trial 13MM	17261	FDA UDI	Class I	Active
Hbs Screw 2.5 X 20mm S. C. Pkg	20402	FDA UDI	Class II	Active
X-Plate Large Sterile	20960	FDA UDI	Class II	Active
Insert Total 10x62	10260	FDA UDI	Class II	Active
MTP Fusion Plate MD-8 Right	21492	FDA UDI	Class II	Active
BioPro Bipolar Head 42mm	18134	FDA UDI	Class II	Active
12mm Fusion Nail, Left	21593	FDA UDI	Class II	Active
Cortical Screw 2.0mm x 10mm	20479	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.