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BIOPRO, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2929 Lapeer Rd, PORT HURON, MI, 48060
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1832656
DUNS Number: 618749857

Catalogue (3006)

Page 13 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Screw, Low Head, 3.5mm x 36mm	21731	FDA UDI	Class II	Active
Compression Sleeve, Right	21650	FDA UDI	Class I	Active
Cortical Screw, Low Head 3.5mm x 70mm	21287	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 12mm	20558	FDA UDI	Class II	Active
Goez Screw 3.5 X 18mm	18209	FDA UDI	Class II	Active
Insert Uni Md 8.5	10310	FDA UDI	Class II	Active
Y-Shape Fracture Plate 4 holes 2.5/2.8mm	20619	FDA UDI	Class II	Active
3.0 x 16mm HBS Screw	19572	FDA UDI	Class II	Active
Insert Providence 10 Deg 32x52	15089	FDA UDI	Class II	Active
Tray Total 70	10248	FDA UDI	Class II	Active
K-Wire .045" Single Sterile	22764	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 8 Hole	21133	FDA UDI	Class II	Active
10mm Nail Cap + 5mm	21637	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 0mm, left	20746	FDA UDI	Class II	Active
Endo Modular Ceramic Sh 41	13007	FDA UDI	Class II	Active
Locking Drill Guide 2.8mm	20638	FDA UDI	Class I	Active
Cortical Screw, Low Head 3.5mm x 28mm, Sterile	21303	FDA UDI	Class II	Active
MVA Cortical Locking screw 2.0mm x 18mm	20476	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 24mm	21276	FDA UDI	Class II	Active
Kwire single trocar 1.0 x 70mm, Sterile	OL1070S	FDA UDI	Class II	Active
Steinmann Pin Single Trocar Round 12" 2.4MM	21678	FDA UDI	Class II	Active
Straight Fusion Plate 2 holes	20868	FDA UDI	Class II	Active
Impactor Handle	15259	FDA UDI	Class I	Active
Insert Total 13x62	10267	FDA UDI	Class II	Active
Insert Total Mod 10x82	10348	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 6mm	22642	FDA UDI	Class II	Active
Hbs Screw 3.0 X 32mm Sdst	20527	FDA UDI	Class II	Active
HEAD FEMORAL 28mm +6	18591	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 30mm	21229	FDA UDI	Class II	Active
Insert Total Mod 20x66	10375	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 12 MM	21697	FDA UDI	Class I	Active
Goez Screw 4.5 X 12mm	18242	FDA UDI	Class II	Active
Open Wedge Plate, 2.5-2.8mm, 6mm Wedge	20633	FDA UDI	Class II	Active
13mm Fusion Nail, Right	21598	FDA UDI	Class II	Active
Straight Fusion Plate 6 holes Sterile	20788	FDA UDI	Class II	Active
Hbs Screw 3.0 X 10mm S. C. Pkg	20413	FDA UDI	Class II	Active
Medial TMT I Fusion Plate Sterile	20957	FDA UDI	Class II	Active
Cloverleaf Plate 6 holes	20876	FDA UDI	Class II	Active
Cannulated Drill Sterile 4.0-4.5MM	19236	FDA UDI	Class I	Active
Goez Screw 4.5 X 34mm	19032	FDA UDI	Class II	Active
Kwire double trocar 1.6 x 280mm, Sterile	OL28016DS	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 30mm	21279	FDA UDI	Class II	Active
Punch	17786	FDA UDI	Class I	Active
2.8 Plate Module	22930	FDA UDI	Class II	Active
Mod Thumb Oscillating Burr Coarse 12mm	17341	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.5mm x 18mm Sterile	20599	FDA UDI	Class II	Active
Burr Coarse 13MM	19533	FDA UDI	Class I	Active
Straight Fusion Plate 6 holes	20870	FDA UDI	Class II	Active
SMALL STAPLE 9x9	17782	FDA UDI	Class II	Active
Hbs Screw 2.5 X 24mm Sdst	20507	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.