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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 31 of 61

Device	Model / Reference	Registries	Class	Status
Toe Joint Titanium Npc Ms 18.5	17198	FDA UDI	Class II	Active
TOE JOINT NPC 12.5mm W/HOLE	17330	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 95mm	21292	FDA UDI	Class II	Active
Toe Joint Mpj 2nd5th 10.25mm	16820	FDA UDI	Class II	Active
Toe Joint Titanium Npc M/L 21.5mm	16815	FDA UDI	Class II	Active
4.5 x 26mm Go-EZ Screw	18249	FDA UDI	Class II	Active
5 Mm Bone Screw X 80 Mm	21620	FDA UDI	Class II	Active
LARGE STAPLE 20x20	17622	FDA UDI	Class II	Active
ACCU-CUT™ 2mm W/THREADED K-WIRES	18578	FDA UDI	Class I	Active
14mm x 2.5 HBS Sd Comp	19355	FDA UDI	Class II	Active
Driver 1.0mm Star Ao	22299	FDA UDI	Class I	Active
Compression Sleeve, Left	22465	FDA UDI	Class I	Active
11mm x 2.5 HBS Sd Comp	19352	FDA UDI	Class II	Active
17mm x 3 HBS High Comp - S. C.	19190	FDA UDI	Class II	Active
3.0 x 28mm HBS Screw	19584	FDA UDI	Class II	Active
Endo Modular Ceramic Sh 47	13010	FDA UDI	Class II	Active
Stem Broach 11.5MM	19463	FDA UDI	Class I	Active
20mm x 2.5 HBS High Comp	19382	FDA UDI	Class II	Active
Insert Cc 28x53	10067	FDA UDI	Class II	Active
24mm HBS® High Compression	18643	FDA UDI	Class II	Active
4" Non Threaded Sngl Trochar Wire .045	18329	FDA UDI	Class II	Active
14mm HBS® High Compression	18633	FDA UDI	Class II	Active
Straight Fusion Plate 2 holes Sterile	20786	FDA UDI	Class II	Active
38mm X 3.0 Hbs Screw Sdst Pkg	20530	FDA UDI	Class II	Active
Osteotome, 6mm	95-6006	FDA UDI	Class I	Active
34mm X 2.5 Hbs Std Comp-S.c.	19342	FDA UDI	Class II	Active
12mm X 2.5 Hbs Screw Sdst Pkg	20501	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 24mm, Sterile	21301	FDA UDI	Class II	Active
L-Shape Fracture Plate, 3 hole, LEFT	21197	FDA UDI	Class II	Active
Cortical Locking Screw, Mva, 3.5mm X 35mm	20826	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 2mm, right	20753	FDA UDI	Class II	Active
Tray Uni Comp Md	14147	FDA UDI	Class II	Active
Uni Ll/Rm Md	10296	FDA UDI	Class II	Active
Mpj Holder Bracket	16977	FDA UDI	Class I	Active
Angled Staple Punch	17655	FDA UDI	Class I	Active
Memory Staple 11 X 19 X 171.5 X 1.5mm	17636	FDA UDI	Class II	Active
17mm HBS® Standard Compression	18615	FDA UDI	Class II	Active
Sizer 6MM	17481	FDA UDI	Class I	Active
Hbs Screw 2.5 X 32mm S. C. Pkg	20408	FDA UDI	Class II	Active
THUMB MOD HEAD 15mm +4	17508	FDA UDI	Class II	Active
Rod Tibial Medullary 13x150	10355	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 14mm	20559	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 18mm	20819	FDA UDI	Class II	Active
Stem Npc Sh 13	11585	FDA UDI	Class II	Active
Goez Screw 2.0 X 18mm	18168	FDA UDI	Class II	Active
L-Shaped Fracture Plate 3 holes, right 2.5/2.8mm Sterile	20718	FDA UDI	Class II	Active
Accu-Cut™ Two Stage	16957	FDA UDI	Class I	Active
Insert Total 13x74	10270	FDA UDI	Class II	Active
Medial Tibia Plate 6 Hole, left Sterile	21124	FDA UDI	Class II	Active
3.0 x 29mm HBS Screw	19585	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.