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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 17 of 61

Device	Model / Reference	Registries	Class	Status
3.0 x 20mm Go-EZ Screw	18192	FDA UDI	Class II	Active
Hbs Screw 2.5 X 18mm Sdst	20504	FDA UDI	Class II	Active
12mm HBS® High Compression	18631	FDA UDI	Class II	Active
Staple 4 Leg 18x16x15	18067	FDA UDI	Class II	Active
16mm HBS® Standard Compression	18614	FDA UDI	Class II	Active
HEAD FEMORAL 32mm +3	19133	FDA UDI	Class II	Active
Cortical Screw, Low Head, 3.5mm x 32mm Sterile	21725	FDA UDI	Class II	Active
Lesser Mpj Trial 8.0mm	16963	FDA UDI	Class I	Active
MPJ TRIAL 21.5mm (ML)	14959	FDA UDI	Class I	Active
HEAD FEMORAL 28mm +3	18590	FDA UDI	Class II	Active
Goez Screw 4.5 X 24mm	18248	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 18mm	20573	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 8mm Sterile	20654	FDA UDI	Class II	Active
Straight Fracture Plate 5 holes 2.5/2.8mm	20615	FDA UDI	Class II	Active
22mm X 3.0 Hbs Screw Sdst	20327	FDA UDI	Class II	Active
Insert Total Mod 14x62	15033	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 28mm Sterile	21029	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 5 Hole, right, Sterile	21171	FDA UDI	Class II	Active
24mm X 3.0 Hbs Screw Sdst Pkg	20523	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 10 Hole	21135	FDA UDI	Class II	Active
HEAD FEMORAL 28mm +0	18589	FDA UDI	Class II	Active
BioPro	20968	FDA UDI	Class II	Active
Stem Npc Lg 12	11568	FDA UDI	Class II	Active
Staple 4 Leg 14x12x12.5	18063	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 30mm	20567	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 10mm	20486	FDA UDI	Class II	Active
2.5 x 24mm HBS Screw	19559	FDA UDI	Class II	Active
Goez Screw 2.5 X 18mm	18178	FDA UDI	Class II	Active
Depth Gauge Assembly	22411	FDA UDI	Class I	Active
Insert Total Mod 12x78	15040	FDA UDI	Class II	Active
BioPro	22864	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.5mm x 20mm Sterile	20600	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 18mm Sterile	20997	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 22mm	20810	FDA UDI	Class II	Active
Insert Total Mod 12x62	15032	FDA UDI	Class II	Active
10mm Fusion Nail, Right	21350	FDA UDI	Class II	Active
21mm HBS® Standard Compression	18619	FDA UDI	Class II	Active
Toe Joint Titanium Npc Md 20mm	16814	FDA UDI	Class II	Active
Insert Providence 32x54	15077	FDA UDI	Class II	Active
Horizon Titanium Subtalar 6mm	17478	FDA UDI	Class II	Active
Template 5 Prong	17309	FDA UDI	Class I	Active
2.0 x 18mm Go-EZ Screw	18168	FDA UDI	Class II	Active
5 Mm Bone Screw X 76 Mm	21618	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 26mm	20565	FDA UDI	Class II	Active
Trial 11MM	17193	FDA UDI	Class I	Active
Insert Uni Comp Md 11.5	14139	FDA UDI	Class II	Active
Tara Femoral Component 47	10089	FDA UDI	Class II	Active
TOE JOINT NPC 11.00mm W/HOLE	17328	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 10 Hole, left	21156	FDA UDI	Class II	Active
Insert Total Mod 24x70	10383	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.