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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 37 of 61

Device	Model / Reference	Registries	Class	Status
Small Staple Drill Bit 1.8mm	17660	FDA UDI	Class I	Active
19mm HBS® High Compression	18638	FDA UDI	Class II	Active
HEAD FEMORAL 32mm -6	19130	FDA UDI	Class II	Active
Cloverleaf Plate, 3 hole, Sterile	21202	FDA UDI	Class II	Active
Uni Ll/Rm Lg	10297	FDA UDI	Class II	Active
Goez Screw 2.5 X 50mm	19259	FDA UDI	Class II	Active
Goez Screw 3.5 X 14mm	18207	FDA UDI	Class II	Active
Dwyer Plate 4mm Sterile	21044	FDA UDI	Class II	Active
Staple 4 Leg 10x8x10	18259	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 - 7mm Implant	22643	FDA UDI	Class I	Active
MTP Module	22929	FDA UDI	Class II	Active
1.1x230mm Double Trocar	OL23011DS	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 85mm	21290	FDA UDI	Class II	Active
Screw Bone 6.5/15	10723	FDA UDI	Class II	Active
Burr Guide 3 Leg 18x16	18309	FDA UDI	Class I	Active
Stem Trial 11.5MM	17348	FDA UDI	Class I	Active
Cortical Screw, Low Head 3.5mm x 45mm, Sterile	21307	FDA UDI	Class II	Active
38mm X 3.0 Hbs Screw Sdst	20335	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 10 Hole, Sterile	21145	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 55mm, Sterile	21259	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 3 Hole	21178	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 50mm	21233	FDA UDI	Class II	Active
Straight Fracture Plate 7 holes 2.5/2.8mm Sterile	20713	FDA UDI	Class II	Active
Stem Npc Lg 13	11570	FDA UDI	Class II	Active
27mm HBS® Standard Compression	18625	FDA UDI	Class II	Active
ACCU-CUT™ 2 mm MICRO CHOICE	17734	FDA UDI	Class I	Active
Horizon Subtalar Gen 2 7mm	22643	FDA UDI	Class II	Active
12mm x 3 HBS High Comp - S. C.	19185	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3, 0mm x 30mm Sterile	20785	FDA UDI	Class II	Active
HBS SCREW 3.0 x 30mm S.C. PKG	20423	FDA UDI	Class II	Active
2.5 x 8mm Go-EZ Screw	18173	FDA UDI	Class II	Active
4.5 x 44mm Go-EZ Screw	19037	FDA UDI	Class II	Active
Thumb Mod Head Titanium 12mm+4	20234	FDA UDI	Class II	Active
3.5 x 34mm Go-EZ Screw	18217	FDA UDI	Class II	Active
Goez Screw 4.5 X 18mm	18245	FDA UDI	Class II	Active
Drill Sleeve Trocar	21656	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.8mm x 14mm Sterile	20684	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 55mm	20846	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 14.5 MM	22397	FDA UDI	Class I	Active
Drill Guide Locking Bolt	22469	FDA UDI	Class I	Active
Thumb Mod Head Titanium 12mm+2	17801	FDA UDI	Class II	Active
L-Shape Fracture Plate, 3 hole, RIGHT	21199	FDA UDI	Class II	Active
Clover Staple 3 Leg 18mm X 16mm x 12.5mm	18072	FDA UDI	Class II	Active
Memory Staple 11 X 15 X 131.5 X 1.5mm	17634	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 95mm, Sterile	21267	FDA UDI	Class II	Active
2.5 x 22mm Go-EZ Screw	18180	FDA UDI	Class II	Active
K-Wire with stop 1.0mm	22794	FDA UDI	Class II	Active
Clover Staple 4 Leg 18 X 16 X 12.5	18066	FDA UDI	Class II	Active
Implant & Instrument Sterilization Tray	21716	FDA UDI	Class I	Active
6.5 x 50mm Go-EZ Screw	19658	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.