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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 27 of 61

Device	Model / Reference	Registries	Class	Status
SCREW D.C. 1.8 x 35mm	17117	FDA UDI	Class II	Active
MTP Fusion Plate SM-8 Left	21491	FDA UDI	Class II	Active
BioPro Bipolar Head 58mm	18150	FDA UDI	Class II	Active
Impactor Tip (Curved)	17340	FDA UDI	Class I	Active
16mm X 2.5 Hbs Std Comp-S.c.	19333	FDA UDI	Class II	Active
Screw Dispenser Kit	17149	FDA UDI	Class I	Active
Evans Plate 4mm, left Sterile	21036	FDA UDI	Class II	Active
Plug Mod Tray	10324	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 8mm Sterile	20693	FDA UDI	Class II	Active
11mm Fusion Nail, Left	21348	FDA UDI	Class II	Active
5 Mm Bone Screw X 46 Mm	21420	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 40mm	20864	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 5 Hole, left, Sterile	21159	FDA UDI	Class II	Active
Cortical Screw, Low Head, 3.5mm x 38mm Sterile	21728	FDA UDI	Class II	Active
4.5 x 40mm Go-EZ Screw	19035	FDA UDI	Class II	Active
Staple 4 Leg 18x16x12.5	18066	FDA UDI	Class II	Active
MTP Fusion Plate MD-13 Left Sterile	21498	FDA UDI	Class II	Active
Burr Guide 3 Leg 14x12	18310	FDA UDI	Class I	Active
Cortical Screw 3.5mm x 10mm	21219	FDA UDI	Class II	Active
HEAD FEMORAL 28mm -6	19003	FDA UDI	Class II	Active
Insert Total Mod 24x66	10382	FDA UDI	Class II	Active
Medial Tibia Plate 12 Hole, left Sterile	21127	FDA UDI	Class II	Active
Screw Driver Blade T6	20650	FDA UDI	Class I	Active
K-wire Threaded .062" x 4" Double Trochar	18577	FDA UDI	Class II	Active
Goez Screw 3.0 X 34mm	18199	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 100mm, Sterile	21318	FDA UDI	Class II	Active
Insert Cc 28x58	10069	FDA UDI	Class II	Active
Medial 4 Column Plate, short, right Sterile	21048	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 15 MM	21700	FDA UDI	Class I	Active
10mm X 2.5 Hbs Screw Sdst Pkg	20500	FDA UDI	Class II	Active
Medial Tibia Plate 12 Hole, left	21121	FDA UDI	Class II	Active
Evans Plate 4mm, right Sterile	21040	FDA UDI	Class II	Active
Hbs Screw 3.0 X 28mm Sdst	20525	FDA UDI	Class II	Active
Goez Screw 2.5 X 10mm	18174	FDA UDI	Class II	Active
2.5 x 21mm HBS Screw	19556	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 14 Hole, left	21158	FDA UDI	Class II	Active
Tray Mod 62	10325	FDA UDI	Class II	Active
HEAD FEMORAL 22mm -3	18593	FDA UDI	Class II	Active
14mm x 2.5 HBS High Comp	19376	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 14mm, Sterile	21246	FDA UDI	Class II	Active
12mm X 3.0 Hbs Screw Sdst Pkg	20517	FDA UDI	Class II	Active
K-wire .030" x 12" Double Trochar	18683	FDA UDI	Class II	Active
SS Guide Wire .060" PKG	22687	FDA UDI	Class II	Active
TMT I Medial Fusion Plate Sterile	20730	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 75mm, Sterile	21263	FDA UDI	Class II	Active
5 Mm Bone Screw X 56 Mm	21425	FDA UDI	Class II	Active
Insert Total 20x74	10284	FDA UDI	Class II	Active
Medial Distal Column Plate, short Sterile	21057	FDA UDI	Class II	Active
Apollo Labral Anchor, Peek 2.5mm x 13mm	S-2513	FDA UDI	Class II	Active
MPJ TRIAL 17mm (SM)	12235	FDA UDI	Class I	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.