Is this your brand? Sign in to claim ownership.

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 26 of 61

Device	Model / Reference	Registries	Class	Status
Insert Total 16x78	10278	FDA UDI	Class II	Active
Insert Cc 28x63	10071	FDA UDI	Class II	Active
13mm x 2.5 HBS High Comp	19375	FDA UDI	Class II	Active
Goez Screw 2.5 X 44mm	19256	FDA UDI	Class II	Active
Burr Guide 4 Leg 10x8	18296	FDA UDI	Class I	Active
12mm Fusion Nail, Right	21589	FDA UDI	Class II	Active
TOE POROUS COATED LARGE 23mm	10414	FDA UDI	Class II	Active
BioPro Kwire .062" Sterile Packed	22765	FDA UDI	Class II	Active
29mm x 2.5 HBS Sd Comp	19370	FDA UDI	Class II	Active
3.5 x 36mm Go-EZ Screw	18218	FDA UDI	Class II	Active
26mm HBS® Standard Compression	18624	FDA UDI	Class II	Active
Goez Screw 6.5 X 70mm	19662	FDA UDI	Class II	Active
Drill Guide 4 Leg 10x8	18290	FDA UDI	Class I	Active
Drill Guide 3 Leg 18x16	18304	FDA UDI	Class I	Active
3.0 x 18mm HBS Screw	19574	FDA UDI	Class II	Active
12mm Fusion Nail, Right	21597	FDA UDI	Class II	Active
SMALL STAPLE 7x5	17628	FDA UDI	Class II	Active
Toe Joint Npc Lg W/Bevel	16629	FDA UDI	Class II	Active
Pusher 4 leg 14x12	18300	FDA UDI	Class I	Active
Cortical Screw 3.0mm x 38mm sterile	21552	FDA UDI	Class II	Active
T25 Screw Driver	21390	FDA UDI	Class I	Active
Standard Spreader	20661	FDA UDI	Class I	Active
Cortical Locking Screw 3.5mm x 26mm	20860	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 8 Hole, left	21155	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3, 0mm x 28mm Sterile	20784	FDA UDI	Class II	Active
T-Shape Fracture Plate, 6 Holes Sterile	20946	FDA UDI	Class II	Active
Goez Screw 3.0 X 24mm	18194	FDA UDI	Class II	Active
5 Mm Bone Screw X 38 Mm	21356	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 9 Hole, Sterile	21194	FDA UDI	Class II	Active
BioPro Bipolar Head 53mm	18145	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 12mm	20487	FDA UDI	Class II	Active
Toe Joint Cobalt Chrome Pc Lg 23mm	10414	FDA UDI	Class II	Active
MTP-FUSION REAMER, concave Ø21mm	20673	FDA UDI	Class I	Active
Cortical Screw 2.0mm x 18mm Sterile	20592	FDA UDI	Class II	Active
HEAD FEMORAL 36mm +3	19055	FDA UDI	Class II	Active
VA Drill Guide 2.0mm	20640	FDA UDI	Class I	Active
Goez Screw 2.0 X 42mm	19273	FDA UDI	Class II	Active
Hbs Screw 2.5 X 12mm Sdst	20501	FDA UDI	Class II	Active
Patella Poly 36	10319	FDA UDI	Class II	Active
Insert Uni Xlg 8.5	10316	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 95mm	21242	FDA UDI	Class II	Active
HBS K- Wire	18669	FDA UDI	Class II	Active
Evans Plate 6mm, left	20889	FDA UDI	Class II	Active
THUMB MOD HEAD 12mm +4	17500	FDA UDI	Class II	Active
Insert Providence 10 Deg 32x54	15090	FDA UDI	Class II	Active
Head Femoral 28 Lg Lt	14091	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 50mm Sterile	21034	FDA UDI	Class II	Active
Hbs Screw 2.5 X 26mm Sdst	20508	FDA UDI	Class II	Active
Toe Non Porous Coated W/Hole M/L	17743	FDA UDI	Class II	Active
Hohman Retractors 8mm	20934	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.