openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 10
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Number: 128667; UDI: 00810012480086
Distribution pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
device · product 2 of 10
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Number: 125423, 128356; UDI: 00810012480093
Distribution pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
device · product 3 of 10
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Number: 124738, 127602; UDI: 00810012480109
Distribution pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
device · product 4 of 10
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Number: 125672, 128357; UDI: 00810012480116
Distribution pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
device · product 5 of 10
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Number: 124735, 128448, 126522; UDI: 00810012480239
Distribution pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
device · product 6 of 10
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Number: 127603, 125590; UDI: 00810012480246
Distribution pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
device · product 7 of 10
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Number: 124737, 125470; UDI: M20917037
Distribution pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
device · product 8 of 10
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Number: 124926; UDI: M209 17038
Distribution pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
device · product 9 of 10
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Number: 128361; UDI: 00810012480277
Distribution pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
device · product 10 of 10
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Lot Number: 125651; UDI: M20917198
Distribution pattern
US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
