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 45 of 61

Device	Model / Reference	Registries	Class	Status
16mm x 2.5 HBS High Comp	19378	FDA UDI	Class II	Active
THUMB MOD STEM COBALT TPS 7.5mm	17596	FDA UDI	Class II	Active
13mm Nail Cap + 5mm	21640	FDA UDI	Class II	Active
Ruler for the MTP Fusion Reamer 12/14/16	20830	FDA UDI	Class I	Active
Cortical Screw, Low Head 3.5mm x 26mm, Sterile	21302	FDA UDI	Class II	Active
ORIF Standard Calc Plate, long Sterile	21063	FDA UDI	Class II	Active
HBS SCREW 3.0 x 14mm S.C. PKG	20415	FDA UDI	Class II	Active
Bone Cement Acetabular Gouge, 20mm	95-7186	FDA UDI	Class II	Active
Endo Modular Ceramic Md 47	13017	FDA UDI	Class II	Active
Insert Total 12x78	15012	FDA UDI	Class II	Active
Kwire Threaded Sterile Single Trochar .045	19109	FDA UDI	Class II	Active
24mm x 2.5 HBS High Comp	19386	FDA UDI	Class II	Active
Stem Pc Xshort 5	17046	FDA UDI	Class II	Active
Insert Total 24x66	10289	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 8mm	20556	FDA UDI	Class II	Active
Stem Pc Lg 11	11565	FDA UDI	Class II	Active
Goez Screw 2.0 X 22mm	18170	FDA UDI	Class II	Active
VA Drill Guide 2.5-2.8mm Screws	20641	FDA UDI	Class I	Active
THUMB MOD STEM TITANIUM TPS 8.5mm	17601	FDA UDI	Class II	Active
Insert Total Mod 24x78	10385	FDA UDI	Class II	Active
Posterior Tibia Plate 2 Hole, Sterile	21151	FDA UDI	Class II	Active
3.0 x 19mm HBS Screw	19575	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 100mm	21327	FDA UDI	Class II	Active
Drill Guide 3 Leg 14x12	18303	FDA UDI	Class I	Active
14mm X 3.0 Hbs Std Ft Pkg	22542	FDA UDI	Class II	Active
Tray Total 66	10247	FDA UDI	Class II	Active
Cortical Screw 2.8mm X 40 mm sterile	21520	FDA UDI	Class II	Active
Insert Total Mod 8 X 74	10335	FDA UDI	Class II	Active
Insert Total 14x78	15013	FDA UDI	Class II	Active
Endo Md 41	10180	FDA UDI	Class II	Active
SMALL STAPLE 7x7	17781	FDA UDI	Class II	Active
30mm HBS® Standard Compression	18628	FDA UDI	Class II	Active
3.0 x 19mm HBS Screw	19575	FDA UDI	Class II	Active
K-Wire Sterile 0.9mmx70mm Sng Trocar	22830	FDA UDI	Class II	Active
Horizon Hybrid Subtalar 9mm	17086	FDA UDI	Class II	Active
Kwire double trocar 0.9 x 150mm, Sterile	OL15009DS	FDA UDI	Class II	Active
Impactor Tip LG	15257	FDA UDI	Class I	Active
4" Non Threaded Sngl Trochar Wire .062	18332	FDA UDI	Class II	Active
2.0 x 22mm Go-EZ Screw	18170	FDA UDI	Class II	Active
Goez Screw 4.0 X 46mm	19048	FDA UDI	Class II	Active
BioPro	22922	FDA UDI	Class II	Active
Staple 4 Leg 14x12x10	18062	FDA UDI	Class II	Active
Thumb Tmc Md 17.5mm	14268	FDA UDI	Class II	Active
Cortical Locking Screw, 3.5mm x 32mm Sterile	21761	FDA UDI	Class II	Active
Insert Total 8x74	10256	FDA UDI	Class II	Active
Toe Joint Cobalt Chrome Pc M/S 18.5mm	17034	FDA UDI	Class II	Active
HEMI EDGE™ TOE MEDIUM 20.00mm	19540	FDA UDI	Class II	Active
Burr Guide 4 Leg 14x12	18297	FDA UDI	Class I	Active
2.5 x 11mm HBS Screw	19546	FDA UDI	Class II	Active
4.0 x 38mm Go-EZ Screw	19044	FDA UDI	Class II	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.