TOE JOINT TITANIUM PC SM 17MM 17035Recalls & reported problems
Biopro, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- 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-0686-2022 · Root cause: Labeling design · Recall details · 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-0687-2022 · Feb 1, 2022 · TerminatedTitanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
- Z-0691-2022 · Feb 1, 2022 · TerminatedTitanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
- Z-0690-2022 · Feb 1, 2022 · TerminatedTitanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
- Z-0688-2022 · Feb 1, 2022 · TerminatedTitanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
- Z-0685-2022 · Feb 1, 2022 · TerminatedTitanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
- Z-0682-2022 · Feb 1, 2022 · TerminatedTitanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
- Z-0684-2022 · Feb 1, 2022 · TerminatedTitanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
- Z-0683-2022 · Feb 1, 2022 · TerminatedTitanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
- Z-0689-2022 · Feb 1, 2022 · TerminatedTitanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
Other Prosthesis, Toe, Hemi-, Phalangeal devices
- TOE JOINT TITANIUM NPC LG 23MM 16816Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM NPC MD 20MM 16814Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM NPC M/L 21.5MM 16815Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM NPC SM 17MM 16813Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM PC MD 20MM 17036Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM PC M/S 18.5MM 17197Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- BioPoly® Great Toe Hemiarthroplasty Implant 135-5118Biopoly, LLC · Prosthesis, Toe, Hemi-, Phalangeal3 reports
- BioPoly® Great Toe Hemiarthroplasty Implant 135-5114Biopoly, LLC · Prosthesis, Toe, Hemi-, Phalangeal2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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