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BIOPRO, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2929 Lapeer Rd, PORT HURON, MI, 48060
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1832656
DUNS Number: 618749857

Catalogue (3006)

Page 60 of 61

Device	Model / Reference	Registries	Class	Status
Cannulated Drill 2.02.5mm	19092	FDA UDI	Class II	Active
3.5 x 18mm Go-EZ Screw	18209	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 45mm Sterile	21077	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 10mm Sterile	20655	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 7 Hole	21182	FDA UDI	Class II	Active
3.0 x 13mm HBS Screw	19569	FDA UDI	Class II	Active
HEAD FEMORAL 22mm +0	18594	FDA UDI	Class II	Active
9mm Fusion Nail, Right	21349	FDA UDI	Class II	Active
26mm x 3 HBS Std Comp - S. C.	19220	FDA UDI	Class II	Active
Insert Cc 28x46	10064	FDA UDI	Class II	Active
3.0 x 30mm Go-EZ Screw	18197	FDA UDI	Class II	Active
18mm X 3.0 Hbs Std Ft	22576	FDA UDI	Class II	Active
Patella Poly 42	11779	FDA UDI	Class II	Active
Clover Staple 3 Leg 14mm x 12mm x 10mm	18068	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 12.5 MM	22394	FDA UDI	Class I	Active
Kwire single trocar threaded tip 2.5 x 230mm, Sterile	OL23025THS	FDA UDI	Class II	Active
Regent Dispo Sterile Biogel Starch Free Surg Glove	K874099	FDA 510(k)	Class I	Active
Wujin #3 Tibial Bone Plate	K011460	FDA 510(k)	Class II	Active
Shotel Ankle Arthrodesis Nail System	K163627	FDA 510(k)	Class II	Active
Biopro Memory Staple, Models 18062-18073	K072298	FDA 510(k)	Class II	Active
Biopro - Infinity Plate Anchor System	K132510	FDA 510(k)	Class II	Active
Biopro Bipolar Head, Models 18130-18152	K082705	FDA 510(k)	Class II	Active
Wujin #3 Femoral Nail	K010149	FDA 510(k)	Class II	Active
Biopro Trinity Acetabular Cup	K904207	FDA 510(k)	Class II	Active
Biopro Metal Backed Cemented Acetabular Cup	K910352	FDA 510(k)	Class II	Active
Townley Great Toe Joint	K911378	FDA 510(k)	Class II	Active
Biopro K-Wire, Models 16863, 17231, 17232, 18577, 18682-18685	K083490	FDA 510(k)	Class II	Active
Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599	K061089	FDA 510(k)	Class II	Active
Biopro Anatomic Unicompartmental Knee	K890044	FDA 510(k)	Class II	Active
BioPro Foot Plating Systems	K162674	FDA 510(k)	Class II	Active
Modular Thumb Implant, Models 17065, 17066, 17243, 17067, 17199, 17238, 17005, 17239, 17006, 17240, 17007, 17241, 17500, 17501, 17507	K052596	FDA 510(k)	Class II	Active
Biopro Proximal Femoral Articular Replacement	K894604	FDA 510(k)	Class II	Active
Biopro Ziralloy Modular Femoral Heads, Modified	K925682	FDA 510(k)	Class II	Active
Townley Cox Comb Acetabular Component	K882869	FDA 510(k)	Class II	Active
Biopro Go-Ez Screw	K081149	FDA 510(k)	Class II	Active
Modification To Hbs Headless Bone Screw	K101030	FDA 510(k)	Class II	Active
Biopro 32mm Ball	K872856	FDA 510(k)	Class II	Active
Biopro Ziralloy Modular Femoral Heads	K912641	FDA 510(k)	Class II	Active
Biopro Drg Custom Hip Replacement System	K920145	FDA 510(k)	Class II	Active
Biopro Polar Head	K100761	FDA 510(k)	Class II	Active
Providence Cup System	K990821	FDA 510(k)	Class II	Active
Biopro Glenoid Component W/ Keel & W/ Posts	K001046	FDA 510(k)	Class II	Active
Toe Mp Joint, Models 10412-10414, 14958, 14960, 1060-10062, 16818, -16822, 16867-16870	K041595	FDA 510(k)	Class II	Active
Psl Total Hip Replacement System	K922500	FDA 510(k)	Class II	Active
Biopro Modular Tibial Tray	K922841	FDA 510(k)	Class II	Active
Biopro Hemi-Endo Modular Head For Psl System	K895886	FDA 510(k)	Class II	Active
Biopro Memory Staple	K061798	FDA 510(k)	Class II	Active
Townley Total Knee (ttk)	K904448	FDA 510(k)	Class II	Active
Biopro Tara Femoral Resurfacing Component	K043542	FDA 510(k)	Class II	Active
Wujin #3 Femoral Bone Plate	K011459	FDA 510(k)	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.