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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 56 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Locking Screw, 4.0mm x 34mm	21722	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 10mm	20831	FDA UDI	Class II	Active
Cloverleaf Plate 4 holes 2.5/2.8mm Sterile	20723	FDA UDI	Class II	Active
Hbs Screw 3.0 X 12mm Sdst	20517	FDA UDI	Class II	Active
2.5 x 10mm HBS Screw	19545	FDA UDI	Class II	Active
5 Mm Bone Screw X 36 Mm	21415	FDA UDI	Class II	Active
Fibula Plate 4 Hole, left Sterile	21091	FDA UDI	Class II	Active
Thumb Tmc Sm 11.5mm	14260	FDA UDI	Class II	Active
Toe Joint Titanium Npc M/L 21.5mm	16815	FDA UDI	Class II	Active
Insert Total 24x74	10291	FDA UDI	Class II	Active
Mtp Fusion Plate 5 Degree, Left	23079	FDA UDI	Class II	Active
K-Wire Threaded Sterile Single Trochar .035	19107	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm x 12mm Sterile	20683	FDA UDI	Class II	Active
Osteotome, 20mm	95-2020	FDA UDI	Class I	Active
30mm HBS® High Compression	18649	FDA UDI	Class II	Active
Medial Tibial Plate 6 Hole, right	21106	FDA UDI	Class II	Active
Insert Total Mod 8 X 66	10333	FDA UDI	Class II	Active
Hbs Screw 2.5 X 32mm Sdst	20511	FDA UDI	Class II	Active
40mm X 2.5 Hbs Screw Sdst	20320	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 Sizing Probe 7mm	22656	FDA UDI	Class I	Active
27mm HBS® High Compression	18646	FDA UDI	Class II	Active
Stem Pc Lg 5	10124	FDA UDI	Class II	Active
Anchor Pin	17647	FDA UDI	Class II	Active
Head Trial 14MM+2	17266	FDA UDI	Class I	Active
Stem Pc Lg 8	10127	FDA UDI	Class II	Active
Impactor Tip LG	18285	FDA UDI	Class I	Active
MVA Cortical Locking Screw, 3, 0mm x 12mm Sterile	20776	FDA UDI	Class II	Active
Pusher 3 Leg 18x16	18313	FDA UDI	Class I	Active
Mtp Fusion Plate, Narrow 0 Degree, Right	23088	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 26mm	20577	FDA UDI	Class II	Active
Bone Cement Cup Splitter	95-7187	FDA UDI	Class II	Active
Impactor Tip Lg	18285	FDA UDI	Class I	Active
MVA Cortical Locking Screw 3.5mm x 26mm	20823	FDA UDI	Class II	Active
Osteotome, Curved, 12mm	95-1212C	FDA UDI	Class I	Active
Goez Screw 2.0 X 44mm	19274	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 50mm Sterile	21018	FDA UDI	Class II	Active
Effi+pro Pin 3.0mm	20196	FDA UDI	Class I	Active
First MPJ Instrument Tray	18060	FDA UDI	Class I	Active
Curved Trocar Cannula	21391	FDA UDI	Class I	Active
Compression Nut	21651	FDA UDI	Class I	Active
Cortical Screw, Low Head, 3.5mm x 38mm	21732	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 30mm	20841	FDA UDI	Class II	Active
TOE JOINT NPC 14.00mm	16870	FDA UDI	Class II	Active
Round Carbide Burr 5.0MM	18277	FDA UDI	Class I	Active
Straight Low Contact Locking Plate 16 Hole, Sterile	21148	FDA UDI	Class II	Active
Tara Femoral Component 53	10092	FDA UDI	Class II	Active
Medial Tibial Plate 12 Hole, right Sterile	21115	FDA UDI	Class II	Active
10mm X 2.5 Hbs Screw Sdst	20305	FDA UDI	Class II	Active
MTP Fusion Plate Left Sterile	20706	FDA UDI	Class II	Active
Insert Uni Comp Xlg 11.5	14145	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.