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 5 of 61

Device	Model / Reference	Registries	Class	Status
Straight Fracture Plate 5 Holes 2mm	20603	FDA UDI	Class II	Active
22mm X 3.0 Hbs Screw Sdst Pkg	20522	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 26mm Sterile	21028	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 6 Hole, Sterile	21191	FDA UDI	Class II	Active
First MPJ Sizer Template LG	22994	FDA UDI	Class I	Unknown
Endo Modular Ceramic Md 45	13016	FDA UDI	Class II	Active
Endo Md 43	10181	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 18mm Sterile	20659	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 14mm Sterile	20696	FDA UDI	Class II	Active
Goez Screw 4.5 X 46mm	19038	FDA UDI	Class II	Active
40mm X 3.0 Hbs Screw Sdst	20336	FDA UDI	Class II	Active
30mm X 2.5 Hbs Std Comp-S.c.	19340	FDA UDI	Class II	Active
Thumb Mod Head Titanium 13mm	17798	FDA UDI	Class II	Active
Insert Uni Sm 8.5	10307	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 5 Hole, left	21153	FDA UDI	Class II	Active
TOE NON POROUS COATED LARGE 23mm	10062	FDA UDI	Class II	Active
25mm x 2.5 HBS High Comp	19387	FDA UDI	Class II	Active
Insert Total Mod 20x82	10379	FDA UDI	Class II	Active
Insert Total 13x66	10268	FDA UDI	Class II	Active
29mm HBS® High Compression	18648	FDA UDI	Class II	Active
Horizon Titanium Subtalar 8mm	17221	FDA UDI	Class II	Active
Horizon Subtalar Complete Kit	22797	FDA UDI	Class I	Active
MTP-FUSION REAMER, concave Ø14mm	20670	FDA UDI	Class I	Active
MVA Cortical Locking screw 2.0mm x 8mm	20471	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 8 Hole, right, Sterile	21173	FDA UDI	Class II	Active
12mm X 3.0 Hbs Screw Sdst	20322	FDA UDI	Class II	Active
6.5 x 45mm Go-EZ Screw	19657	FDA UDI	Class II	Active
Goez Screw 3.5 X 46mm	18223	FDA UDI	Class II	Active
Burr Guide 3 Leg 10x8	18308	FDA UDI	Class I	Active
Endo Modular Ceramic Sh 55	14825	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 14 MM	21699	FDA UDI	Class I	Active
LARGE STAPLE 25x22	17623	FDA UDI	Class II	Active
29mm x 2.5 HBS High Comp	19391	FDA UDI	Class II	Active
HBS SCREW 3.0 x 22mm S.C. PKG	20419	FDA UDI	Class II	Active
4.5 x 16mm Go-EZ Screw	18244	FDA UDI	Class II	Active
Goez Screw 4.5 X 38mm	19034	FDA UDI	Class II	Active
Insert Providence 10 Deg 28x60	15088	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 22mm, Sterile	21250	FDA UDI	Class II	Active
Wrist Staple Instrument Tray	19480	FDA UDI	Class I	Active
Hbs Screw 3.0 X 18mm Sdst	20520	FDA UDI	Class II	Active
Stem Pc Lg 6	10125	FDA UDI	Class II	Active
Insert Uni Xlg 6.5	10315	FDA UDI	Class II	Active
Drill, Guide, Right	21648	FDA UDI	Class I	Active
Cortical Screw, Low Head, 3.5mm x 32mm	21729	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 10mm Sterile	20595	FDA UDI	Class II	Active
3.5 x 32mm Go-EZ Screw	18216	FDA UDI	Class II	Active
4" Threaded K-Wire .062	18331	FDA UDI	Class II	Active
2.5 x 10mm Go-EZ Screw	18174	FDA UDI	Class II	Active
Cortical Screw 2.8mm X 36 mm	21512	FDA UDI	Class II	Active
3.0 x 25mm HBS Screw	19581	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.