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TOE JOINT TITANIUM NPC MD 20MM 16814Recalls & reported problems

Biopro, Inc. · Class 2 · Implant

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

9 other recalls cover devices cleared under the same FDA submission (K041595); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Feb 1, 2022Terminated

    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.

    Z-0683-2022 · Root cause: Labeling design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041595. One submission often covers many models, so check the product and lot details in each record.

  • Z-0686-2022 · Feb 1, 2022 · Terminated
    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
  • Z-0685-2022 · Feb 1, 2022 · Terminated
    Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
  • Z-0684-2022 · Feb 1, 2022 · Terminated
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
  • Z-0691-2022 · Feb 1, 2022 · Terminated
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
  • Z-0682-2022 · Feb 1, 2022 · Terminated
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
  • Z-0690-2022 · Feb 1, 2022 · Terminated
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
  • Z-0689-2022 · Feb 1, 2022 · Terminated
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
  • Z-0687-2022 · Feb 1, 2022 · Terminated
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
  • Z-0688-2022 · Feb 1, 2022 · Terminated
    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037

Other Prosthesis, Toe, Hemi-, Phalangeal devices

All Prosthesis, Toe, Hemi-, Phalangeal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.