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BIOPRO, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2929 Lapeer Rd, PORT HURON, MI, 48060
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1832656
DUNS Number: 618749857

Catalogue (3006)

Page 42 of 61

Device	Model / Reference	Registries	Class	Status
HBS SCREW 2.5 x 12mm S.C. PKG	20398	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 12 Hole	21136	FDA UDI	Class II	Active
Hbs Screw 2.5 X 30mm S. C. Pkg	20407	FDA UDI	Class II	Active
Insert Total 20x66	10282	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 38mm sterile	21540	FDA UDI	Class II	Active
Toe Joint Titanium Pc M/L 21.5mm	17037	FDA UDI	Class II	Active
Toe Joint Titanium Npc M/S 18.5mm	17198	FDA UDI	Class II	Active
Head Femoral 32 Sh Lt	14094	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 16mm	20834	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 36mm sterile	21563	FDA UDI	Class II	Active
K-Wire Sterile Single Trochar 2mm	19871	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 18mm Sterile	21008	FDA UDI	Class II	Active
16mm x 2.5 HBS Sd Comp	19357	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 50mm, Sterile	21308	FDA UDI	Class II	Active
Goez Screw 2.5 X 26mm	18182	FDA UDI	Class II	Active
Goez Screw 3.5 X 30mm	18215	FDA UDI	Class II	Active
L-Shaped Fracture Plate 3 holes right 2.5/2.8mm	20622	FDA UDI	Class II	Active
Thumb Mod Head Titanium 15mm+4	20237	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 5 Hole	21180	FDA UDI	Class II	Active
Implant Screw System Sterilization Tray	21704	FDA UDI	Class I	Active
Screw Driver Blade T8	20651	FDA UDI	Class I	Active
40mm X 3 Hbs Std Comp - S. C.	19219	FDA UDI	Class II	Active
4" Threaded K-Wire .045	18328	FDA UDI	Class II	Active
2.0 x 14mm Go-EZ Screw	18166	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 8 Hole, left, Sterile	21161	FDA UDI	Class II	Active
HBS SCREW 2.5 x 26mm S.C. PKG	20405	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 85mm, Sterile	21215	FDA UDI	Class II	Active
Y-Shape Fracture Plate 3 Holes 2mm Sterile	21204	FDA UDI	Class II	Active
Tendon Anchor System 1 Hole 10mm	20070	FDA UDI	Class II	Active
Hbs Screw 2.5 X 40mm S. C. Pkg	20412	FDA UDI	Class II	Active
30mm X 3.0 Hbs Screw Sdst	20331	FDA UDI	Class II	Active
K-Wire Threaded .062"	18577	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 16mm Sterile	21023	FDA UDI	Class II	Active
Uni Lm/Rl Xxlg	10304	FDA UDI	Class II	Active
22mm x 2.5 HBS High Comp	19384	FDA UDI	Class II	Active
K-Wire .035 x 4" Double Trochar	17231	FDA UDI	Class II	Active
Memory Staple 15 X 121.5 X 1.5mm/Sm	17633	FDA UDI	Class II	Active
MEDIUM STAPLE 18x18x15	17626	FDA UDI	Class II	Active
4.5 x 8mm Go-EZ Screw	18240	FDA UDI	Class II	Active
2.0 x 36mm Go-EZ Screw	19270	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 24mm	20838	FDA UDI	Class II	Active
MTP Fusion Plate SM-13 Right	21486	FDA UDI	Class II	Active
THUMB MOD HEAD 15mm +2	17241	FDA UDI	Class II	Active
12mm Nail Cap	21632	FDA UDI	Class II	Active
Medial 4 Column Plate, long, left	20903	FDA UDI	Class II	Active
THUMB MOD HEAD 12mm	17199	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 16mm Sterile	20996	FDA UDI	Class II	Active
Large Staple Clamp	17652	FDA UDI	Class I	Active
Memory Staple 11 X 101.5 X 1.5mm/Sm	17631	FDA UDI	Class II	Active
4.5 x 32mm Go-EZ Screw	19031	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.