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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 8 of 61

Device	Model / Reference	Registries	Class	Status
Insert Total 20x62	10281	FDA UDI	Class II	Active
24mm X 3.0 Hbs Screw Sdst	20328	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 80mm, Sterile	21332	FDA UDI	Class II	Active
Endo Modular Ceramic Sh 45	13009	FDA UDI	Class II	Active
Cortical Bone Screw 4.5/20mm	16582	FDA UDI	Class II	Active
34mm X 3.0 Hbs Screw Sdst	20333	FDA UDI	Class II	Active
Accu-Cut™ Two Stage Micro	17735	FDA UDI	Class I	Active
Cortical Screw 2.0mm x 10mm Sterile	20588	FDA UDI	Class II	Active
Staple Positioner 10x8	19512	FDA UDI	Class I	Active
Oscillating Burr Coarse 13mm	17342	FDA UDI	Class I	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 15.5 MM	22399	FDA UDI	Class I	Active
MVA Cortical Locking Screw, 3, 0mm x 18mm Sterile	20779	FDA UDI	Class II	Active
Toe Hemi Edge PC MD	19817	FDA UDI	Class II	Active
23mm x 3 HBS High Comp - S. C.	19196	FDA UDI	Class II	Active
Goez Screw 6.5 X 90mm	19666	FDA UDI	Class II	Active
Implant & Instrument Sterilization Tray	21706	FDA UDI	Class I	Active
2.0 x 10mm Go-EZ Screw	18164	FDA UDI	Class II	Active
Toe Joint Titanium Npc Sm 17mm	16813	FDA UDI	Class II	Active
K-Wire 2mm X 170mm For 6.5mm Screws	19750	FDA UDI	Class II	Active
Wrist Staple Instrument Tray	19480	FDA UDI	Class I	Active
Lesser Mpj Hemi Complete Kit	16979	FDA UDI	Class I	Active
Guiding Handle	18650	FDA UDI	Class I	Active
Goez Screw 6.5 X 36mm	19654	FDA UDI	Class II	Active
Mtp Fusion Plate, Narrow 10 Degree, Right	23084	FDA UDI	Class II	Active
15mm HBS® Standard Compression	18613	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 24mm	21743	FDA UDI	Class II	Active
4.0 x 24mm Go-EZ Screw	18235	FDA UDI	Class II	Active
15mm Nail Cap	21635	FDA UDI	Class II	Active
11mm x 3 HBS High Comp - S. C.	19184	FDA UDI	Class II	Active
BioPro Bipolar Head 56mm	18148	FDA UDI	Class II	Active
MTP-FUSION REAMER, convex Ø21mm	20679	FDA UDI	Class I	Active
Screw Driver Blade T10	20929	FDA UDI	Class I	Active
2.0 x 32mm Go-EZ Screw	19268	FDA UDI	Class II	Active
HEAD FEMORAL 32mm -3	18539	FDA UDI	Class II	Active
6.5 x 100mm Go-EZ Screw	19668	FDA UDI	Class II	Active
Memory Staple Complete Kit	17707	FDA UDI	Class I	Active
Cortical Screw 2.8mm x 16mm. Sterile	20697	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 24mm	20859	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 30mm	20579	FDA UDI	Class II	Active
Goez Screw 2.5 X 32mm	19250	FDA UDI	Class II	Active
22mm x 2.5 HBS Sd Comp	19363	FDA UDI	Class II	Active
6" Dbl Trocar Wire 1.4x150mm	22822	FDA UDI	Class II	Active
4.0 x 22mm Go-EZ Screw	18234	FDA UDI	Class II	Active
Goez Screw 3.0 X 36mm	18200	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 22mm	20575	FDA UDI	Class II	Active
HEAD FEMORAL 28mm +9	18592	FDA UDI	Class II	Active
30mm X 3.0 Hbs Screw Sdst Pkg	20526	FDA UDI	Class II	Active
Toe Joint Npc Md W/Bevel	16627	FDA UDI	Class II	Active
Uni Lm/Rl Sm	10300	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 28mm	21228	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.