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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 57 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Screw 2.0mm x 16mm Sterile	20591	FDA UDI	Class II	Active
Hbs 2.5mm Screw 1.68mm Drill Sterile	19684	FDA UDI	Class I	Active
Drill Guide, Left	21647	FDA UDI	Class I	Active
Cortical Locking Screw 4.0mm x 22mm	20837	FDA UDI	Class II	Active
Insert Total 8x78	10257	FDA UDI	Class II	Active
Effi+pro Sterilization Lid	20190	FDA UDI	Class I	Active
18mm X 3.0 Hbs Screw Sdst	20325	FDA UDI	Class II	Active
3.0 x 12mm HBS Screw	19568	FDA UDI	Class II	Active
Insert Cc 26 X 58	11800	FDA UDI	Class II	Active
Hbs Screw 2.5 X 22mm S. C. Pkg	20403	FDA UDI	Class II	Active
SMALL STAPLE 11x15x13	17634	FDA UDI	Class II	Active
3.0 x 32mm Go-EZ Screw	18198	FDA UDI	Class II	Active
TOE NON-POROUS COATED MEDIUM LARGE 21.5mm	14958	FDA UDI	Class II	Active
Osteotome, 10mm	95-1010	FDA UDI	Class I	Active
Hbs Screw 2.5 X 36mm Sdst	20513	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 20mm Sterile	20699	FDA UDI	Class II	Active
Goez Screw 2.5 X 20mm	18179	FDA UDI	Class II	Active
Head Trial 15MM	17263	FDA UDI	Class I	Active
Evans Plate 8mm, right	20894	FDA UDI	Class II	Active
Patella Poly 38	11778	FDA UDI	Class II	Active
MTP Fusion Plate MD-13 Right	21488	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 40mm	20827	FDA UDI	Class II	Active
4.5 x 20mm Go-EZ Screw	18246	FDA UDI	Class II	Active
3.5 x 38mm Go-EZ Screw	18219	FDA UDI	Class II	Active
Open Wedge Plate 0mm	20628	FDA UDI	Class II	Active
Insert Providence 10 Deg 28x52	15084	FDA UDI	Class II	Active
TOE JOINT NPC 14.00mm W/HOLE	17332	FDA UDI	Class II	Active
Small Reduction Forceps	20932	FDA UDI	Class I	Active
Stem Pc Xshort 3	17044	FDA UDI	Class II	Active
27mm x 3 HBS High Comp - S. C.	19200	FDA UDI	Class II	Active
5 Mm Bone Screw X 30 Mm	21412	FDA UDI	Class II	Active
Pusher 4 Leg 18x16	18301	FDA UDI	Class I	Active
Cortical Screw, Low Head 3.5mm x 30mm, Sterile	21304	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 7 Hole, Sterile	21142	FDA UDI	Class II	Active
Insert Total Mod 13x82	10361	FDA UDI	Class II	Active
Insert Cc 32x50	10075	FDA UDI	Class II	Active
First Mpj Instrument Tray	18060	FDA UDI	Class I	Active
Cotton Plate 4mm Sterile	20962	FDA UDI	Class II	Active
6.5 x 30mm Go-EZ Screw	19651	FDA UDI	Class II	Active
Kwire single trocar 0.9 x 150mm, Sterile	OL15009S	FDA UDI	Class II	Active
11mm HBS® High Compression	18630	FDA UDI	Class II	Active
SMALL STAPLE 11x10	17631	FDA UDI	Class II	Active
Head Trial 13MM+4	17614	FDA UDI	Class I	Active
2.5 x 15mm HBS Screw	19550	FDA UDI	Class II	Active
Reduction Sleeve	18657	FDA UDI	Class I	Active
Goez Screw 6.5 X 120mm	19672	FDA UDI	Class II	Active
TOE POROUS COATED MEDIUM LARGE 21.5mm	14960	FDA UDI	Class II	Active
TOE JOINT TITANIUM NPC SMALL 17mm	16813	FDA UDI	Class II	Active
Drill bit AO QC 3.5 x 195mm, Sterile	OL35DBSL	FDA UDI	Class I	Active
5 Mm Bone Screw X 72 Mm	21616	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.