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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 29 of 61

Device	Model / Reference	Registries	Class	Status
Goez Screw 4.0 X 6mm	18226	FDA UDI	Class II	Active
Head Trial 12MM	17260	FDA UDI	Class I	Active
Effi+pro Pin 2.4mm	20197	FDA UDI	Class I	Active
Fibula Plate 8 Hole, left	21088	FDA UDI	Class II	Active
Goez Screw 4.0 X 18mm	18232	FDA UDI	Class II	Active
Tray Mod 66	10326	FDA UDI	Class II	Active
Tara Femoral Component 55	10093	FDA UDI	Class II	Active
Evans Plate 8mm, left Sterile	21038	FDA UDI	Class II	Active
HBS SCREW 3.0 x 24mm S.C. PKG	20420	FDA UDI	Class II	Active
Hbs Screw 3.0 X 26mm Sdst	20524	FDA UDI	Class II	Active
40mm X 3.0 Hbs Screw Sdst Pkg	20531	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 13.5 MM	22396	FDA UDI	Class I	Active
13mm Fusion Nail, Left	21586	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 60mm	20847	FDA UDI	Class II	Active
Drill bit AO QC 4.5 x 145/120mm, Sterile	OL45DBS	FDA UDI	Class I	Active
Nut Wrench	21652	FDA UDI	Class I	Active
Cortical Locking Screw 4.0mm x 35mm	20842	FDA UDI	Class II	Active
Screw Driver Handle Small	20653	FDA UDI	Class I	Active
Curved Trocar Assy	21392	FDA UDI	Class I	Active
2.0 x 50mm Go-EZ Screw	19277	FDA UDI	Class II	Active
10mm HBS® High Compression	18629	FDA UDI	Class II	Active
12mm STEP STAPLE 20X20-2X3	17720	FDA UDI	Class II	Active
3.0 x 17mm HBS Screw	19573	FDA UDI	Class II	Active
Kwire double trocar 1.0 x 150mm, Sterile	OL15010DS	FDA UDI	Class II	Active
6mm STEP STAPLE 15X20-2X2	17715	FDA UDI	Class II	Active
Depth Gauge	18378	FDA UDI	Class I	Active
Osteotome, 8mm	95-8008	FDA UDI	Class I	Active
Screw Bone 6.5/35	10727	FDA UDI	Class II	Active
4.0 x 50mm Go-EZ Screw	19050	FDA UDI	Class II	Active
Uni Ll/Rm Xlg	10298	FDA UDI	Class II	Active
Goez Screw 3.5 X 24mm	18212	FDA UDI	Class II	Active
Goez Screw 2.0 X 34mm	19269	FDA UDI	Class II	Active
Screw Driver Handle Medium	20930	FDA UDI	Class I	Active
Goez Screw 6.5 X 45mm	19657	FDA UDI	Class II	Active
Straight Fracture Plate 6 holes 2.5/2.8mm Sterile	20712	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 70mm, Sterile	21262	FDA UDI	Class II	Active
Insert Total Mod 16x86	10373	FDA UDI	Class II	Active
Insert Total 13x82	10272	FDA UDI	Class II	Active
32mm X 2.5 Hbs Screw Sdst	20316	FDA UDI	Class II	Active
1.2x150mm Single Trocar	OL15012S	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 14mm	20571	FDA UDI	Class II	Active
5 Mm Bone Screw X 74 Mm	21607	FDA UDI	Class II	Active
Straight Fracture Plate 4 Holes 2mm	20602	FDA UDI	Class II	Active
Insert Uni Md 11.5	10308	FDA UDI	Class II	Active
2.5 x 28mm HBS Screw	19563	FDA UDI	Class II	Active
MTP Fusion Plate MD-8 Right Sterile	21501	FDA UDI	Class II	Active
3.0-3.5 Screw Module	22928	FDA UDI	Class II	Active
Goez Screw 2.0 X 48mm	19276	FDA UDI	Class II	Active
5 Mm Bone Screw X 20 Mm	21611	FDA UDI	Class II	Active
Measuring Sleeve	18658	FDA UDI	Class I	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.