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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 34 of 61

Device	Model / Reference	Registries	Class	Status
Clover Staple # Leg Complete Kit	19678	FDA UDI	Class I	Active
Drill Guide 11 13mm	17649	FDA UDI	Class I	Active
Tray Total 86	10252	FDA UDI	Class II	Active
Goez Screw 2.5 X 38mm	19253	FDA UDI	Class II	Active
Goez Screw 6.5 X 95mm	19667	FDA UDI	Class II	Active
Memory Staple 9 X 71.2 X 1.2mm/Xsm	17638	FDA UDI	Class II	Active
Fibula Plate 3 Hole, right	21095	FDA UDI	Class II	Active
Fibula Plate 8 Hole, right Sterile	21103	FDA UDI	Class II	Active
28mm HBS® Standard Compression	18626	FDA UDI	Class II	Active
L-Shaped Fracture Plate 4 holes, left Sterile	20789	FDA UDI	Class II	Active
HEAD FEMORAL 36mm +0	19054	FDA UDI	Class II	Active
26mm x 3 HBS High Comp - S. C.	19199	FDA UDI	Class II	Active
25mm HBS® Standard Compression	18623	FDA UDI	Class II	Active
Stem Pc Sh 5	10134	FDA UDI	Class II	Active
Tray Uni Comp Sm	14146	FDA UDI	Class II	Active
Goez Screw 2.0 X 26mm	19265	FDA UDI	Class II	Active
Insert Uni Sm 6.5	10306	FDA UDI	Class II	Active
Burr Coarse 14MM	19534	FDA UDI	Class I	Active
21mm x 2.5 HBS Sd Comp	19362	FDA UDI	Class II	Active
Goez Screw 2.5 X 28mm	18183	FDA UDI	Class II	Active
MPJ TRIAL 23mm (LG)	12237	FDA UDI	Class I	Active
Goez Screw 6.5 X 32mm	19652	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 90mm	21241	FDA UDI	Class II	Active
34mm X 2.5 Hbs Screw Sdst	20317	FDA UDI	Class II	Active
Endo Sh 47	10192	FDA UDI	Class II	Active
2.5 x 14mm HBS Screw	19549	FDA UDI	Class II	Active
Drill Staple X-Small (1.4mm)	17659	FDA UDI	Class I	Active
First MPJ Hemi Complete Set	17368	FDA UDI	Class I	Active
2.5 x 18mm HBS Screw	19553	FDA UDI	Class II	Active
Small Staple Punch	17654	FDA UDI	Class I	Active
Toe Non Porous Coated W/Hole Sm	17740	FDA UDI	Class II	Active
Cortical Locking Screw, 3.5mm x 34mm	21766	FDA UDI	Class II	Active
36mm X 2.5 Hbs Std Comp-S.c.	19343	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 11mm	22647	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 - 8mm Implant	22644	FDA UDI	Class II	Active
Insert Providence 10 Deg 32x56	15091	FDA UDI	Class II	Active
29mm x 3 HBS High Comp - S. C.	19202	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 95mm, Sterile	21317	FDA UDI	Class II	Active
THUMB MOD STEM COBALT TPS 10.0mm	17598	FDA UDI	Class II	Active
TOE JOINT NPC 13.25mm	16869	FDA UDI	Class II	Active
Goez Screw 2.5 X 46mm	19257	FDA UDI	Class II	Active
Insert Total 24x70	10290	FDA UDI	Class II	Active
Drill Bit Blue 2.0mm 115mm AO	226780	FDA UDI	Class I	Active
Curved Guide Wire Ss	22383	FDA UDI	Class II	Active
Cortical Screw, 3.5mm x 36mm	21735	FDA UDI	Class II	Active
Insert Total Mod 8 X 78	10336	FDA UDI	Class II	Active
Goez Screw Instrument Tray	18400	FDA UDI	Class I	Active
Osteotome, Bone Cement, Bevelled, Curved, 310mm X 5mm	95-7423	FDA UDI	Class I	Active
Memory Staple 13 X 101.5 X 1.5mm/Sm	17632	FDA UDI	Class II	Active
Tendon Anchor System 2 Hole 26mm	20159	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.