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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 9 of 61

Device	Model / Reference	Registries	Class	Status
Endo Md 51	10185	FDA UDI	Class II	Active
Cortical Locking Screw, 3.5mm x 38mm Sterile	21764	FDA UDI	Class II	Active
Driver	17228	FDA UDI	Class I	Active
Goez Screw 4.5 X 8mm	18240	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 12mm Sterile	21021	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 34mm sterile	21549	FDA UDI	Class II	Active
Drill Sleeve Trocar	21387	FDA UDI	Class I	Active
2.5 x 28mm HBS Screw	19563	FDA UDI	Class II	Active
10mm X 3 Hbs Std Comp - S. C.	19204	FDA UDI	Class II	Active
Staple 3 Leg 14x12x15	18070	FDA UDI	Class II	Active
20mm HBS® Standard Compression	18618	FDA UDI	Class II	Active
27mm x 2.5 HBS Sd Comp	19368	FDA UDI	Class II	Active
Toe Porous Coated W/Hole M/L	17748	FDA UDI	Class II	Active
Stem Pc Sh 8	10137	FDA UDI	Class II	Active
Tray Uni Sm	10320	FDA UDI	Class II	Active
13mm Nail Cap	21633	FDA UDI	Class II	Active
Medial 3 Column Plate, short, right	20904	FDA UDI	Class II	Active
Osteotome, 4mm	95-4004	FDA UDI	Class I	Active
Memory Staple 18 X18 X 152 X 2mm/Md	17626	FDA UDI	Class II	Active
K-Wire with stop 1.4mm	20941	FDA UDI	Class II	Active
Stem Pc Sh 6	10135	FDA UDI	Class II	Active
Modular Osteotome Handle Assembly	21759	FDA UDI	Class I	Active
Cortical Locking Screw, 3.5mm x 32mm	21765	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 3mm, right Sterile	20955	FDA UDI	Class II	Active
THUMB MOD STEM 11.5mm	17067	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 28mm	21278	FDA UDI	Class II	Active
BioPro	22920	FDA UDI	Class II	Active
Medial Tibial Plate 6 Hole, right Sterile	21112	FDA UDI	Class II	Active
Burr Cutter	18315	FDA UDI	Class I	Active
Goez Screw 6.5 X 85mm	19665	FDA UDI	Class II	Active
Cortical Screw 2.8mm X 36 mm sterile	21518	FDA UDI	Class II	Active
Insert Total Mod 12x70	15036	FDA UDI	Class II	Active
5 Mm Bone Screw X 34 Mm	21354	FDA UDI	Class II	Active
Impactor Tip SM	18284	FDA UDI	Class I	Active
Rod Tibial Medullary 14x150	10364	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 6 Hole	21181	FDA UDI	Class II	Active
3.0 x 15mm HBS Screw	19571	FDA UDI	Class II	Active
Depth Gauge Body	22410	FDA UDI	Class I	Active
Cotton Plate 4mm	20883	FDA UDI	Class II	Active
12mm Fusion Nail, Left	21585	FDA UDI	Class II	Active
19mm HBS® Standard Compression	18617	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 90mm, Sterile	21316	FDA UDI	Class II	Active
22mm X 2.5 Hbs Screw Sdst Pkg	20506	FDA UDI	Class II	Active
Insert Total Mod 24x82	10386	FDA UDI	Class II	Active
Insert Total 13x86	10273	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 8 Hole	21183	FDA UDI	Class II	Active
Tray Total 62	10246	FDA UDI	Class II	Active
L-Shaped Fracture Plate 4 holes right 2.5/2.8mm	20623	FDA UDI	Class II	Active
Insert Uni Comp Xlg 8.5	14143	FDA UDI	Class II	Active
Goez Screw 3.0 X 14mm	18189	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.