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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 59 of 61

Device	Model / Reference	Registries	Class	Status
Straight Low Contact Locking Plate 12 Hole, Sterile	21146	FDA UDI	Class II	Active
MPJ Trial 20mm (MD)	12236	FDA UDI	Class I	Active
HBS SCREW 3.0 x 18mm S.C. PKG	20417	FDA UDI	Class II	Active
Insert Total 24x78	10292	FDA UDI	Class II	Active
Medial Tibia Plate 10 Hole, left Sterile	21126	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 70mm	21321	FDA UDI	Class II	Active
Uni Ll/Rm Sm	10295	FDA UDI	Class II	Active
Insert Total Mod 16x70	10369	FDA UDI	Class II	Active
MTP-FUSION REAMER, convex Ø24mm	20680	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.5mm x 20mm	21581	FDA UDI	Class II	Active
9mm Nail Cap + 5mm	21625	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 24mm, Sterile	21251	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 14 Hole, right	21170	FDA UDI	Class II	Active
Insert Total 12x82	15014	FDA UDI	Class II	Active
Rod Tibial Medullary 14x50	10363	FDA UDI	Class II	Active
Endo Modular Ceramic Md 51	13019	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 22mm Sterile	21010	FDA UDI	Class II	Active
6.5 x 105mm Go-EZ Screw	19669	FDA UDI	Class II	Active
Open Wedge Plate 4mm	20631	FDA UDI	Class II	Active
Hbs Screw 3.0 X 38mm Sdst	20530	FDA UDI	Class II	Active
24mm x 3 HBS High Comp - S. C.	19197	FDA UDI	Class II	Active
2.5 x 23mm HBS Screw	19558	FDA UDI	Class II	Active
Toe Hemi Edge PC ML	19818	FDA UDI	Class II	Active
Medial Tibial Plate 4 Hole, right Sterile	21111	FDA UDI	Class II	Active
Goez Screw 3.5 X 44mm	18222	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm x 8mm Sterile	20681	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 2 Hole	21177	FDA UDI	Class II	Active
Goez Screw 4.5 X 6mm	18239	FDA UDI	Class II	Active
Plantar TMT Plate Left Sterile	21507	FDA UDI	Class II	Active
5 Mm Bone Screw X 58 Mm	21426	FDA UDI	Class II	Active
SCREW D.C. 1.5 x 45mm	17113	FDA UDI	Class II	Active
9mm Nail Cap	21433	FDA UDI	Class II	Active
Insert Total Mod 12x66	15034	FDA UDI	Class II	Active
Fasciotome 2.64mm	20434	FDA UDI	Class I	Active
Cortical Screw 3.5mm x 10mm, Sterile	21244	FDA UDI	Class II	Active
HBS SCREW 2.5 x 10mm S.C. PKG	20397	FDA UDI	Class II	Active
13mm Nail Cap + 5mm	21629	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 14mm Sterile	20657	FDA UDI	Class II	Active
SMALL STAPLE 11x19x17	17636	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 38mm Sterile	21774	FDA UDI	Class II	Active
Goez Screw 4.5 X 30mm	18251	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 12 Hole	21186	FDA UDI	Class II	Active
2.5 x 13mm HBS Screw	19548	FDA UDI	Class II	Active
2.0 x 46mm Go-EZ Screw	19275	FDA UDI	Class II	Active
29mm HBS® Standard Compression	18627	FDA UDI	Class II	Active
15mm HBS® High Compression	18634	FDA UDI	Class II	Active
Large Staple Drill Bit 3.0mm	17662	FDA UDI	Class II	Active
4.5 x 48mm Go-EZ Screw	19039	FDA UDI	Class II	Active
Stem Pc Xshort 8	17338	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 18mm	20797	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.