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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 35 of 61

Device	Model / Reference	Registries	Class	Status
Insert Total 16x74	10277	FDA UDI	Class II	Active
Effi+pro Pin 2.8mm/5-Coil	20193	FDA UDI	Class I	Active
HEAD FEMORAL 28mm -3	18588	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 24mm	20811	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 22mm	20858	FDA UDI	Class II	Active
Endo Sh 49	10193	FDA UDI	Class II	Active
Osteotome, Curved, 6mm	95-6006C	FDA UDI	Class I	Active
MTP-FUSION REAMER, concave Ø12mm	20669	FDA UDI	Class I	Active
Cortical Screw 3.5mm x 85mm	21240	FDA UDI	Class II	Active
32mm X 2.5 Hbs Screw Sdst Pkg	20511	FDA UDI	Class II	Active
Nitinol Guide Wire	21393	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 12mm	20816	FDA UDI	Class II	Active
4.0 x 20mm Go-EZ Screw	18233	FDA UDI	Class II	Active
Splitting Chisel, 5mm	95-7546	FDA UDI	Class I	Active
Goez Screw 6.5 X 110mm	19670	FDA UDI	Class II	Active
Goez Screw 4.5 X 16mm	18244	FDA UDI	Class II	Active
2.5 x 27mm HBS Screw	19562	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 30mm	20825	FDA UDI	Class II	Active
Stem Pc Sh 12	11581	FDA UDI	Class II	Active
Horizon Subralar Gen 2 Removal Driver	22654	FDA UDI	Class I	Active
Straight Low Contact Locking Plate 5 Hole	21130	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 85mm	21211	FDA UDI	Class II	Active
Straight Fracture Plate 5 holes 2.5/2.8mm Sterile	20711	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 28mm	20802	FDA UDI	Class II	Active
6.5 x 32mm Go-EZ Screw	19652	FDA UDI	Class II	Active
Insert Total 10x82	10265	FDA UDI	Class II	Active
Insert Total 10x70	10262	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 26mm	21227	FDA UDI	Class II	Active
30mm X 2.5 Hbs Screw Sdst Pkg	20510	FDA UDI	Class II	Active
26mm x 2.5 HBS High Comp	19388	FDA UDI	Class II	Active
Plating System Base Instrument Tray	22891	FDA UDI	Class II	Active
Knee Rt 74	10242	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 35mm Sterile	21015	FDA UDI	Class II	Active
Burr Coarse 15MM	19535	FDA UDI	Class I	Active
Cortical Screw, Low Head 3.5mm x 70mm, Sterile	21312	FDA UDI	Class II	Active
HBS SCREW 3.0 x 26mm S.C. PKG	20421	FDA UDI	Class II	Active
Kwire single trocar 2.0 x 310mm, Sterile	OL31020S	FDA UDI	Class II	Active
Horizon Titanium Subtalar 6mm	17478	FDA UDI	Class II	Active
2.5 x 15mm HBS Screw	19550	FDA UDI	Class II	Active
Staple 3 Leg 10x8x15	18264	FDA UDI	Class II	Active
Toe Joint Npc Ml W/Bevel	16628	FDA UDI	Class II	Active
Trial 6MM	17479	FDA UDI	Class I	Active
Cortical Bone Screw 4.5/50mm	16588	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm x 22mm Sterile	20688	FDA UDI	Class II	Active
HEAD FEMORAL CERAMIC 28mm -3	19023	FDA UDI	Class II	Active
Insert Total 14x86	15017	FDA UDI	Class II	Active
Horizon Titanium Subtalar 7mm	17803	FDA UDI	Class II	Unknown
3.5 x 44mm Go-EZ Screw	18222	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 65mm, Sterile	21261	FDA UDI	Class II	Active
Insert Total Mod 14x74	15039	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.