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BioPro, Inc. FDA Recalls
16 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDClass IISep 9, 2025Potential packaging issue that could compromise the sterile |
| BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMClass IISep 9, 2025Potential packaging issue that could compromise the sterile |
| BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMOClass IISep 9, 2025Potential packaging issue that could compromise the sterile |
| BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMClass IISep 9, 2025Potential packaging issue that could compromise the sterile |
| BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MMClass IISep 9, 2025Potential packaging issue that could compromise the sterile |
| BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51Class IISep 9, 2025Potential packaging issue that could compromise the sterile |
| Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813Class IIFeb 1, 2022There is an incorrect statement regarding MR Compatibility i |
| Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037Class IIFeb 1, 2022There is an incorrect statement regarding MR Compatibility i |
| Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197Class IIFeb 1, 2022There is an incorrect statement regarding MR Compatibility i |
| Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198Class IIFeb 1, 2022There is an incorrect statement regarding MR Compatibility i |
| Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814Class IIFeb 1, 2022There is an incorrect statement regarding MR Compatibility i |
| Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038Class IIFeb 1, 2022There is an incorrect statement regarding MR Compatibility i |
| Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035Class IIFeb 1, 2022There is an incorrect statement regarding MR Compatibility i |
| Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815Class IIFeb 1, 2022There is an incorrect statement regarding MR Compatibility i |
| Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816Class IIFeb 1, 2022There is an incorrect statement regarding MR Compatibility i |
| Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036Class IIFeb 1, 2022There is an incorrect statement regarding MR Compatibility i |