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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 3 of 61

Device	Model / Reference	Registries	Class	Status
Insert Total 20x78	10285	FDA UDI	Class II	Active
Goez Screw 6.5 X 34mm	19653	FDA UDI	Class II	Active
Horizon Titanium Subtalar 8mm	17221	FDA UDI	Class II	Active
BioPro	22916	FDA UDI	Class II	Active
XSMALL STAPLE 7x9	19225	FDA UDI	Class II	Active
4.5 x 14mm Go-EZ Screw	18243	FDA UDI	Class II	Active
HEAD FEMORAL CERAMIC 32mm +0	19026	FDA UDI	Class II	Active
THUMB MOD STEM 7.5mm	17065	FDA UDI	Class II	Active
Goez Screw 3.5 X 42mm	18221	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 12mm Sterile	20656	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 40mm	21547	FDA UDI	Class II	Active
3.0 x 30mm HBS Screw	19586	FDA UDI	Class II	Active
Head Remover	19832	FDA UDI	Class I	Active
Horizon Subtalar Gen 2 Sizing Probe 11mm	22660	FDA UDI	Class I	Active
22mm HBS® High Compression	18641	FDA UDI	Class II	Active
28mm X 3.0 Hbs Std Ft Pkg	22549	FDA UDI	Class II	Active
28mm x 2.5 HBS Sd Comp	19369	FDA UDI	Class II	Active
3.0 x 22mm HBS Screw	19578	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 100mm	21214	FDA UDI	Class II	Active
Goez Screw 3.0 X 38mm	18201	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 75mm	20850	FDA UDI	Class II	Active
Fibula Plate 4 Hole, right	21096	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 50mm, Sterile	21258	FDA UDI	Class II	Active
Clover Staple 4 Leg 18 X 16 X 15	18067	FDA UDI	Class II	Active
Insert Total Mod 8 X 82	10337	FDA UDI	Class II	Active
Insert Cc 28x55	10068	FDA UDI	Class II	Active
BioPro	22795	FDA UDI	Class II	Active
Burr Fine 12MM	19758	FDA UDI	Class I	Active
Cortical Screw 3.5mm x 14mm	21221	FDA UDI	Class II	Active
16mm x 3 HBS High Comp - S. C.	19189	FDA UDI	Class II	Active
Medial Tibial Plate 8 Hole, right Sterile	21113	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 40mm Sterile	21032	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 24mm	20576	FDA UDI	Class II	Active
18mm X 3.0 Hbs Std Ft Pkg	22544	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 40mm	20843	FDA UDI	Class II	Active
5 Mm Bone Screw X 48 Mm	21421	FDA UDI	Class II	Active
Fibula Plate 8 Hole, left Sterile	21093	FDA UDI	Class II	Active
6.5 x 40mm Go-EZ Screw	19656	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 Sizing Probe 9mm	22658	FDA UDI	Class I	Active
K-Wire Sterile Single Trochar .062	19110	FDA UDI	Class II	Active
Goez Screw 3.5 X 32mm	18216	FDA UDI	Class II	Active
Horizon Titanium Subtalar 11mm	17224	FDA UDI	Class II	Active
Insert Providence 32x60	15080	FDA UDI	Class II	Active
Insert Total Mod 14x82	15043	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 10mm	20804	FDA UDI	Class II	Active
Insert Cc 32x67	10082	FDA UDI	Class II	Active
3.0 x 27mm HBS Screw	19583	FDA UDI	Class II	Active
3.5 x 6mm Go-EZ Screw	18203	FDA UDI	Class II	Active
2.5 x 21mm HBS Screw	19556	FDA UDI	Class II	Active
24mm X 2.5 Hbs Std Comp-S.c.	19337	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.