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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 12 of 61

Device	Model / Reference	Registries	Class	Status
2.5 x 32mm Go-EZ Screw	19250	FDA UDI	Class II	Active
Toe Joint Npc 8.00mm W/Hole	17324	FDA UDI	Class II	Active
Rod Tibial Medullary 10x150	10342	FDA UDI	Class II	Active
TOE JOINT NPC 9.5mm	16819	FDA UDI	Class II	Active
Hbs Screw 2.5 X 28mm S. C. Pkg	20406	FDA UDI	Class II	Active
19mm x 2.5 HBS High Comp	19381	FDA UDI	Class II	Active
Medial Suture Anchor, PEEK 6.5mm x 15mm	M-6515	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 35mm, Sterile	21305	FDA UDI	Class II	Active
Goez Screw 6.5 X 50mm	19658	FDA UDI	Class II	Active
Easy Out Tool	18665	FDA UDI	Class I	Active
Insert Un-I Xlg 11.5	10314	FDA UDI	Class II	Active
T-Shape Fracture Plate 4 Holes 2.5/2.8mm Sterile	20721	FDA UDI	Class II	Active
3.5 x 16mm Go-EZ Screw	18208	FDA UDI	Class II	Active
Kwire double trocar 2.0 x 150mm, Sterile	OL15020DS	FDA UDI	Class II	Active
Clover Staple 3 Leg 14mm x 12mm x 15mm	18070	FDA UDI	Class II	Active
6.5 x 34mm Go-EZ Screw	19653	FDA UDI	Class II	Active
9mm STEP STAPLE 20X20-2X3	17719	FDA UDI	Class II	Active
Fibula Plate 4 Hole, right Sterile	21101	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 10mm Sterile	21020	FDA UDI	Class II	Active
Drill bit AO QC 3.5 x 110/85mm, Sterile	OL35DBS	FDA UDI	Class I	Active
HEAD FEMORAL 32mm +0	19132	FDA UDI	Class II	Active
Cloverleaf Plate 4 holes Sterile	20943	FDA UDI	Class II	Active
Cortical Screw, Low Head, 3.5mm x 34mm Sterile	21726	FDA UDI	Class II	Active
24mm X 3.0 Hbs Std Ft Pkg	22547	FDA UDI	Class II	Active
MTP-FUSION REAMER, concave Ø16mm	20671	FDA UDI	Class I	Active
26mm X 2.5 Hbs Screw Sdst	20313	FDA UDI	Class II	Active
Rod Tibial Medullary 11x50	10350	FDA UDI	Class II	Active
Cortical Screw 2.0mm x 20mm Sterile	20593	FDA UDI	Class II	Active
14mm Nail Cap	21634	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 100mm, Sterile	21268	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 2 Hole, Sterile	21187	FDA UDI	Class II	Active
THUMB MOD STEM TITANIUM TPS 7.5mm	17600	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 50mm	21283	FDA UDI	Class II	Active
Horizon Hybrid Subtalar 10mm	17087	FDA UDI	Class II	Active
Removal Driver	17149	FDA UDI	Class I	Active
Cortical Screw, Low Head 3.5mm x 16mm	21272	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 60mm	21235	FDA UDI	Class II	Active
Insert Total Mod 24x62	10381	FDA UDI	Class II	Active
Rod Tibial Medullary 13x50	10354	FDA UDI	Class II	Active
HBS SCREW 3.0 x 40mm S.C. PKG	20428	FDA UDI	Class II	Active
Mtp Fusion Plate 0 Degree, Left	23081	FDA UDI	Class II	Active
14mm Nail Cap	21623	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 60mm, Sterile	21310	FDA UDI	Class II	Active
Drill Bit AO QC 1.5mm	20647	FDA UDI	Class I	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 15.5 MM	22400	FDA UDI	Class I	Active
Cortical Locking Screw 3.5mm x 45mm Sterile	21033	FDA UDI	Class II	Active
28mm HBS® High Compression	18647	FDA UDI	Class II	Active
Fibula Plate 10 Hole, right Sterile	21104	FDA UDI	Class II	Active
Thumb Tmc Md 11.5mm	14264	FDA UDI	Class II	Active
Medial 3 Column Plate, long, right	20906	FDA UDI	Class II	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.