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BioPro, Inc.

FDA Regulatory Profile

Summary

Total Recalls
37
510(k) Clearances
41
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0150-2026Class IIBioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 181September 9, 2025
Z-0152-2026Class IIBioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MSeptember 9, 2025
Z-0153-2026Class IIBioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MSeptember 9, 2025
Z-0149-2026Class IIBioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ESeptember 9, 2025
Z-0151-2026Class IIBioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MMSeptember 9, 2025
Z-0148-2026Class IIBioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/DescriptSeptember 9, 2025
Z-0690-2022Class IITitanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197February 1, 2022
Z-0684-2022Class IITitanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815February 1, 2022
Z-0687-2022Class IITitanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036February 1, 2022
Z-0683-2022Class IITitanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814February 1, 2022
Z-0688-2022Class IITitanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037February 1, 2022
Z-0685-2022Class IITitanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816February 1, 2022
Z-0686-2022Class IITitanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035February 1, 2022
Z-0689-2022Class IITitanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038February 1, 2022
Z-0682-2022Class IITitanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813February 1, 2022
Z-0691-2022Class IITitanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198February 1, 2022
Z-2240-2019Class IIK-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez scJune 25, 2019
Z-2246-2019Class IIGo-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez screw system June 25, 2019
Z-2242-2019Class IIK-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-EJune 25, 2019
Z-2247-2019Class IIGo-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw systemJune 25, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K163627Shotel Ankle Arthrodesis Nail SystemSeptember 14, 2017
K162674BioPro Foot Plating SystemsJune 16, 2017
K132510BIOPRO - INFINITY PLATE ANCHOR SYSTEMOctober 24, 2013
K130298BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEMJune 18, 2013
K121973BIOPRO HEMI-EDGE TOE SYSTEMOctober 30, 2012
K100761BIOPRO POLAR HEADDecember 3, 2010
K101030MODIFICATION TO HBS HEADLESS BONE SCREWJune 3, 2010
K090208BIOPRO FEMORAL HEADSMay 22, 2009
K083490BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685March 18, 2009
K082705BIOPRO BIPOLAR HEAD, MODELS 18130-18152December 15, 2008
K081149BIOPRO GO-EZ SCREWAugust 5, 2008
K072298BIOPRO MEMORY STAPLE, MODELS 18062-18073October 29, 2007
K061798BIOPRO MEMORY STAPLEAugust 21, 2006
K061089MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599June 20, 2006
K052596MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,1724November 15, 2005
K043542BIOPRO TARA FEMORAL RESURFACING COMPONENTMay 18, 2005
K041595TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870November 12, 2004
K041936BIOPRO SUBTALAR IMPLANTSeptember 8, 2004
K011460WUJIN #3 TIBIAL BONE PLATEAugust 7, 2001
K011459WUJIN #3 FEMORAL BONE PLATEAugust 7, 2001