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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 54 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Locking Screw 4.0mm x 55mm Sterile	21079	FDA UDI	Class II	Active
BioPro Bipolar Head 48mm	18140	FDA UDI	Class II	Active
Installation Driver	18032	FDA UDI	Class I	Active
Cortical Locking Screw 4.0mm x 75mm Sterile	21083	FDA UDI	Class II	Active
27mm x 2.5 HBS High Comp	19389	FDA UDI	Class II	Active
Insert Total Mod 8 X 70	10334	FDA UDI	Class II	Active
Trial Punch	17786	FDA UDI	Class I	Active
Medial Suture Anchor, PEEK 5.5mm x 15mm	M-5515	FDA UDI	Class II	Active
Tray Total 78	10250	FDA UDI	Class II	Active
TOE POROUS COATED SMALL 17mm	10412	FDA UDI	Class II	Active
3.0 x 20mm HBS Screw	19576	FDA UDI	Class II	Active
15mm x 2.5 HBS High Comp	19377	FDA UDI	Class II	Active
15mm x 3 HBS High Comp - S. C.	19188	FDA UDI	Class II	Active
Lesser Mpj Trial 12.50mm	16969	FDA UDI	Class I	Active
Stem Broach 10.0MM	19462	FDA UDI	Class I	Active
13mm x 2.5 HBS Sd Comp	19354	FDA UDI	Class II	Active
2.0 x 42mm Go-EZ Screw	19273	FDA UDI	Class II	Active
Trial 12MM	17194	FDA UDI	Class I	Active
14mm Fusion Nail, Left	21595	FDA UDI	Class II	Active
Goez Screw 4.0 X 36mm	19043	FDA UDI	Class II	Active
Foot Plating System Main Tray	22925	FDA UDI	Class II	Active
6.5 x 36mm Go-EZ Screw	19654	FDA UDI	Class II	Active
24mm HBS® Standard Compression	18622	FDA UDI	Class II	Active
2.5 x 22mm HBS Screw	19557	FDA UDI	Class II	Active
3.0 x 16mm Go-EZ Screw	18190	FDA UDI	Class II	Active
MTP Fusion Plate SM-13 Left	21487	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 26mm	20839	FDA UDI	Class II	Active
14mm X 3.0 Hbs Std Ft	22574	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 10mm	20569	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 35mm	20863	FDA UDI	Class II	Active
Drill Bit AO QC 3.0mm / 125mm length	20927	FDA UDI	Class I	Active
11mm Nail Cap	21435	FDA UDI	Class II	Active
Stem Pc Xshort 9	17339	FDA UDI	Class II	Active
4.0 x 44mm Go-EZ Screw	19047	FDA UDI	Class II	Active
Head Trial 13MM+2	17265	FDA UDI	Class I	Active
Kwire Threaded Sterile Single Trochar .062	19111	FDA UDI	Class II	Active
Accu-Cut™ 1mm	19506	FDA UDI	Class I	Active
Tray Uni Comp Xlg	14149	FDA UDI	Class II	Active
Insert Total Mod 8 X 62	10332	FDA UDI	Class II	Active
36mm X 3.0 Hbs Std Ft Pkg	22553	FDA UDI	Class II	Active
34mm X 3.0 Hbs Screw Sdst Pkg	20528	FDA UDI	Class II	Active
Osteotome, 12mm	95-1212	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.8mm X 32mm	21521	FDA UDI	Class II	Active
Open Wedge Plate 3mm	20630	FDA UDI	Class II	Active
Pusher 4 Leg 14x12	18300	FDA UDI	Class I	Active
Goez Screw 4.5 X 40mm	19035	FDA UDI	Class II	Active
Goez Screw 3.0 X 28mm	18196	FDA UDI	Class II	Active
Stem Pc Lg 9	10128	FDA UDI	Class II	Active
Staple Positioner 14x12	19513	FDA UDI	Class I	Active
10mm x 2.5 HBS Sd Comp	19351	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.