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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 38 of 61

Device	Model / Reference	Registries	Class	Status
3.0 x 21mm HBS Screw	19577	FDA UDI	Class II	Active
5 Mm Bone Screw X 76 Mm	21608	FDA UDI	Class II	Active
5 Mm Bone Screw X 56 Mm	21365	FDA UDI	Class II	Active
L-Shaped Fracture Plate 4 holes, left 2.5/2.8mm Sterile	20717	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 22mm	21745	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 10mm	20557	FDA UDI	Class II	Active
Goez Screw 3.0 X 26mm	18195	FDA UDI	Class II	Active
Medial Tibial Plate 12 Hole, right	21109	FDA UDI	Class II	Active
Endo Md 49	10184	FDA UDI	Class II	Active
T-Shape Fracture Plate 4 Holes 2.5/2.8mm	20625	FDA UDI	Class II	Active
Cortical Screw 2.8mm X 34 mm sterile	21516	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 35mm sterile	21550	FDA UDI	Class II	Active
Insert Total Mod 14x86	15045	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 35mm sterile	21562	FDA UDI	Class II	Active
ORIF Standard Calc plate, medium	20914	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 14mm	20833	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 1mm, right	20752	FDA UDI	Class II	Active
Insert Providence 10 Deg 28x48	15082	FDA UDI	Class II	Active
Bending Iron right	20665	FDA UDI	Class I	Active
Insert Total Mod 16x82	10372	FDA UDI	Class II	Active
Insert Total Mod 10x70	10345	FDA UDI	Class II	Active
Knee Lt 66	10217	FDA UDI	Class II	Active
5 Mm Bone Screw X 42 Mm	21418	FDA UDI	Class II	Active
T-Shape Fracture Plate 4 Holes 2mm	20608	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 12 Hole, right, Sterile	21175	FDA UDI	Class II	Active
Depth Gauge 3.0/3.5/4.0 – 50mm	21337	FDA UDI	Class I	Active
Burr Adaptor Stryker TPS	20284	FDA UDI	Class I	Active
T-Shape Fracture Plate 3 Holes 2.5/2.8mm Sterile	20720	FDA UDI	Class II	Active
Insert Providence 28x58	15131	FDA UDI	Class II	Active
Patella Poly 40	10318	FDA UDI	Class II	Active
Insert Cc 28x65	10072	FDA UDI	Class II	Active
K-Wire Sterile 0.9mmx70mm Sng Trocar	22830	FDA UDI	Class II	Active
6.5 x 110mm Go-EZ Screw	19670	FDA UDI	Class II	Active
Tray Uni Md	10321	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 28mm Sterile	21013	FDA UDI	Class II	Active
2.5 x 20mm HBS Screw	19555	FDA UDI	Class II	Active
Hbs Screw 3.0 X 22mm Sdst	20522	FDA UDI	Class II	Active
Stem Pc Sh 3	10132	FDA UDI	Class II	Active
17mm HBS® High Compression	18636	FDA UDI	Class II	Active
4.5 x 34mm Go-EZ Screw	19032	FDA UDI	Class II	Active
BioPro Bipolar Head 49mm	18141	FDA UDI	Class II	Active
2.5 x 46mm Go-EZ Screw	19257	FDA UDI	Class II	Active
6mm STEP STAPLE 20X20-2X3	17718	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 10 Hole, right	21168	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 16mm	20572	FDA UDI	Class II	Active
3.0 x 40mm Go-EZ Screw	18202	FDA UDI	Class II	Active
Goez Screw 4.5 X 42mm	19036	FDA UDI	Class II	Active
Medium Reduction Forceps	20933	FDA UDI	Class I	Active
Goez Screw 4.0 X 22mm	18234	FDA UDI	Class II	Active
Biopro Memory Staple 13x15-1.5x1.5mm Pkg	22774	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.