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 21 of 61

Device	Model / Reference	Registries	Class	Status
Cannulated Drill 6.5mm	19734	FDA UDI	Class I	Active
2.5 x 25mm HBS Screw	19560	FDA UDI	Class II	Active
Cortical Screw 2.0mm x 8mm Sterile	20587	FDA UDI	Class II	Active
Holding and Bending Pin 3.0-3.5-4.0mm	20739	FDA UDI	Class I	Active
12mm HBS® Standard Compression	18610	FDA UDI	Class II	Active
Goez Screw 4.0 X 8mm	18227	FDA UDI	Class II	Active
Straight Fracture Plate 6 Holes 2mm Sterile	20644	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 14mm	20806	FDA UDI	Class II	Active
2.5 x 30mm Go-EZ Screw	18184	FDA UDI	Class II	Active
Starter Probe	17455	FDA UDI	Class I	Active
5 Mm Bone Screw X 32 Mm	21353	FDA UDI	Class II	Active
18mm x 3 HBS High Comp - S. C.	19191	FDA UDI	Class II	Active
26mm X 3.0 Hbs Std Ft Pkg	22548	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 8.5 MM	22386	FDA UDI	Class I	Active
MTP Fusion Plate SM-13 Right Sterile	21495	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm x 16mm Sterile	20685	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 14 Hole, left, Sterile	21164	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 40mm	21559	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 90mm	21212	FDA UDI	Class II	Active
Rod Tibial Medullary 10x50	10341	FDA UDI	Class II	Active
Straight Fracture Plate 8 holes 2mm Sterile	20649	FDA UDI	Class II	Active
Goez Screw 2.0 X 16mm	18167	FDA UDI	Class II	Active
24mm X 3 Hbs Std Comp - S. C.	19211	FDA UDI	Class II	Active
ORIF Calc Plate, long	20912	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 4mm, left	20750	FDA UDI	Class II	Active
Straight Fracture Plate 5 Holes 2mm Sterile	20642	FDA UDI	Class II	Active
HBS SCREW 3.0 x 16mm S.C. PKG	20416	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 60mm Sterile	21080	FDA UDI	Class II	Active
2.5 x 6mm Go-EZ Screw	18172	FDA UDI	Class II	Active
Clover Staple 3leg Complete Kit	19678	FDA UDI	Class I	Active
BioPro	22924	FDA UDI	Class II	Active
4.0 x 6mm Go-EZ Screw	18226	FDA UDI	Class II	Active
Goez Screw 4.0 X 50mm	19050	FDA UDI	Class II	Active
3.5 x 46mm Go-EZ Screw	18223	FDA UDI	Class II	Active
Insert Uni Comp Md 8.5	14137	FDA UDI	Class II	Active
Drill, Guide, Right	21646	FDA UDI	Class I	Active
Locking Drill Guide 3.0mm	20917	FDA UDI	Class I	Active
11mm HBS® Standard Compression	18609	FDA UDI	Class II	Active
Accu-Cut™ Dmaa	19720	FDA UDI	Class I	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 10.5 MM	22389	FDA UDI	Class I	Active
2.5 x 24mm Go-EZ Screw	18181	FDA UDI	Class II	Active
Goez Screw 4.0 X 48mm	19049	FDA UDI	Class II	Active
Goez Screw 3.0 X 10mm	18187	FDA UDI	Class II	Active
Hbs Instrument Tray Ii	19687	FDA UDI	Class I	Active
Cortical Locking Screw, 4.0mm x 34mm Sterile	21718	FDA UDI	Class II	Active
MTP Fusion Revision Plate Right Sterile	20709	FDA UDI	Class II	Active
4.0 x 34mm Go-EZ Screw	19042	FDA UDI	Class II	Active
BioPro Bipolar Head 59mm	18151	FDA UDI	Class II	Active
Tray Mod 86	10331	FDA UDI	Class II	Active
Guide Wire Subtalar 8	17230	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.