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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 2 of 61

Device	Model / Reference	Registries	Class	Status
Clover Staple 4 Leg 14 X 12 X 10	18062	FDA UDI	Class II	Active
Stem Pc Xshort 7	17048	FDA UDI	Class II	Active
Insert Total 8x62	10253	FDA UDI	Class II	Active
Medial Tibia Plate 14 Hole, left	21122	FDA UDI	Class II	Active
30mm x 2.5 HBS Sd Comp	19371	FDA UDI	Class II	Active
20mm X 3.0 Hbs Std Ft	22577	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 9 MM	21396	FDA UDI	Class I	Active
X-Plate Medium	20880	FDA UDI	Class II	Active
ACCU-CUT™ 3mm OFFSET S	17306	FDA UDI	Class I	Active
Accu-Cut™ Standard W/2 Blades	17502	FDA UDI	Class I	Active
Insert Total 10x74	10263	FDA UDI	Class II	Active
Tray Mod 70	10327	FDA UDI	Class II	Active
Sizer 10MM	17187	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.5mm x 26mm sterile	21777	FDA UDI	Class II	Active
4.2mm Drill Bit	21659	FDA UDI	Class I	Active
2.5 x 10mm HBS Screw	19545	FDA UDI	Class II	Active
14mm HBS® Standard Compression	18612	FDA UDI	Class II	Active
Insert Total 20x86	10287	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 28mm	20824	FDA UDI	Class II	Active
Straight Fracture Plate 7 holes 2.5/2.8mm	20617	FDA UDI	Class II	Active
Goez Screw 3.5 X 28mm	18214	FDA UDI	Class II	Active
Endo Modular Ceramic Md 41	13014	FDA UDI	Class II	Active
K-Wire Sterile 1.1mmx150mm Dbl Trocar	22826	FDA UDI	Class II	Active
Cortical Bone Screw 4.5/45mm	16587	FDA UDI	Class II	Active
10mm x 3 HBS High Comp - S. C.	19183	FDA UDI	Class II	Active
20mm X 2.5 Hbs Std Comp-S.c.	19335	FDA UDI	Class II	Active
3.0 x 20mm HBS Screw	19576	FDA UDI	Class II	Active
MTP-FUSION REAMER, convex Ø18mm	20678	FDA UDI	Class I	Active
TOE JOINT NPC 8.0mm	16818	FDA UDI	Class II	Active
2.5 x 17mm HBS Screw	19552	FDA UDI	Class II	Active
10mm X 2.5 Hbs Std Comp-S.c.	19330	FDA UDI	Class II	Active
Xsmall Staple Drill, Sterile	17750	FDA UDI	Class I	Active
22mm X 3.0 Hbs Std Ft Pkg	22546	FDA UDI	Class II	Active
Drill bit AO QC 3.2 x 145/120mm, Sterile	OL32DBS	FDA UDI	Class I	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 8 MM	21395	FDA UDI	Class I	Active
1/3 Locking Tubular Plate 4 Hole	21179	FDA UDI	Class II	Active
Fibula Plate 8 Hole, right	21098	FDA UDI	Class II	Active
Goez Screw 4.5 X 22mm	18247	FDA UDI	Class II	Active
Insert Uni Comp Sm 11.5	14136	FDA UDI	Class II	Active
34mm X 2.5 Hbs Screw Sdst Pkg	20512	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 22mm, Sterile	21300	FDA UDI	Class II	Active
21mm x 2.5 HBS High Comp	19383	FDA UDI	Class II	Active
Memory Staple Instrument Tray	17708	FDA UDI	Class I	Active
Cortical Screw 3.0mm x 24mm Sterile	21000	FDA UDI	Class II	Active
2.0 x 40mm Go-EZ Screw	19272	FDA UDI	Class II	Active
Cortical Locking Screw, 3.5mm x 36mm Sterile	21763	FDA UDI	Class II	Active
Cortical Screw 2.0mm x 20mm	20484	FDA UDI	Class II	Active
Cloverleaf Plate 3 holes 2.5/2.8mm	20626	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 16mm, Sterile	21247	FDA UDI	Class II	Active
Rod Tibial Medullary 15x150	10366	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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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.