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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 51 of 61

Device	Model / Reference	Registries	Class	Status
Insert Total Mod 24x86	10387	FDA UDI	Class II	Active
Open Wedge Plate 5mm	20632	FDA UDI	Class II	Active
Endo Sh 53	10195	FDA UDI	Class II	Active
K-wire .080" x 4" Double Trochar	18684	FDA UDI	Class II	Active
Goez Screw 6.5 X 75mm	19663	FDA UDI	Class II	Active
Goez Screw 4.0 X 24mm	18235	FDA UDI	Class II	Active
MPJ Trial 17MM (SM)	12235	FDA UDI	Class I	Active
Medial Tibia Plate 6 Hole, left	21118	FDA UDI	Class II	Active
26mm x 2.5 HBS Sd Comp	19367	FDA UDI	Class II	Active
BioPro	22862	FDA UDI	Class I	Active
Burr Adaptor Microchoice	18817	FDA UDI	Class I	Active
34mm X 3 Hbs Std Comp - S. C.	19216	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3.5mm x 34mm Sterile	21683	FDA UDI	Class II	Active
Hex Driver 2.0 2.5	18323	FDA UDI	Class I	Active
Cloverleaf Plate 6 holes Sterile	20944	FDA UDI	Class II	Active
2.5 x 16mm Go-EZ Screw	18177	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 95mm	21326	FDA UDI	Class II	Active
Insert Providence 32x58	15079	FDA UDI	Class II	Active
Goez Screw 2.0 X 14mm	18166	FDA UDI	Class II	Active
L-Shape Fracture Plate, 3 hole, LEFT, Sterile	21198	FDA UDI	Class II	Active
36mm X 2.5 Hbs Screw Sdst Pkg	20513	FDA UDI	Class II	Active
Insert Total 14x62	15005	FDA UDI	Class II	Active
16mm X 3.0 Hbs Screw Sdst	20324	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 22mm Sterile	21026	FDA UDI	Class II	Active
Medial Tibial Plate 8 Hole, right	21107	FDA UDI	Class II	Active
MVA Cortical Locking screw 2.0mm x 14mm	20474	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 20mm	20555	FDA UDI	Class II	Active
Insert Providence 28x52	15128	FDA UDI	Class II	Active
Toe Joint Cobalt Chrome Npc Sm 17mm	10060	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 22mm Sterile	20999	FDA UDI	Class II	Active
Insert Providence 28x60	15132	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 95mm, Sterile	21217	FDA UDI	Class II	Active
5 Mm Bone Screw X 32 Mm	21413	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 8 Hole, Sterile	21143	FDA UDI	Class II	Active
First MPJ Sizer Template MS	22991	FDA UDI	Class I	Unknown
3.0 x 24mm Go-EZ Screw	18194	FDA UDI	Class II	Active
HEAD FEMORAL 32mm +12	13136	FDA UDI	Class II	Active
4.5 x 18mm Go-EZ Screw	18245	FDA UDI	Class II	Active
30mm x 2.5 HBS High Comp	19392	FDA UDI	Class II	Active
Osteotome, Curved Lambotte, 25mm	3365125	FDA UDI	Class I	Active
SS Guide Wire .060"	22686	FDA UDI	Class II	Active
10mm Fusion Nail, Right	21410	FDA UDI	Class II	Active
4.0 x 30mm Go-EZ Screw	18238	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 14mm Sterile	21022	FDA UDI	Class II	Active
Tray Mod 82	10330	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 20mm	20857	FDA UDI	Class II	Active
Compression Nut	22467	FDA UDI	Class I	Active
2.0 x 38mm Go-EZ Screw	19271	FDA UDI	Class II	Active
ACCU-CUT™ 1mm OFFSET W/2 BLADES	17503	FDA UDI	Class I	Active
4.0 x 40mm Go-EZ Screw	19045	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.