restor3d MTP 1103-161620Recalls & reported problems
Restor3d, Inc. · CoCr MTP Implant, Large · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840097505244), received between Sep 9, 2026 and Sep 9, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Delivered as Unsterile Product
It was reported that the proof-of-sterilization stickers on MTP Hemiarthroplasty implants were orange in color, rather than red which indicates exposure to sterilant. The implants were not used and the surgeon converted to a different size of the same product line.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694566 ↗
Other Prosthesis, Toe, Hemi-, Phalangeal devices
- TOE JOINT TITANIUM NPC LG 23MM 16816Biopro, 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 MD 20MM 16814Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM PC MD 20MM 17036Biopro, 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 M/S 18.5MM 17197Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- TOE JOINT TITANIUM PC SM 17MM 17035Biopro, Inc. · Prosthesis, Toe, Hemi-, Phalangeal1 recall0 reports
- BioPoly® Great Toe Hemiarthroplasty Implant 135-5118Biopoly, LLC · Prosthesis, Toe, Hemi-, Phalangeal3 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page