FDA recall, , Moderate risk
restor3d MTP Implants
The restor3d MTP Implant may not have been sterilized, as shown by orange sterilization indicators.
Summary by Recall Canary from the FDA notice
What happened
restor3d Inc. recalled its restor3d MTP Implant, a sterile, single-use implant grade metal device used to replace the damaged articulating surface of the first metatarsal distal head, because implants were found in the field with orange sterilization indicators, meaning they were not exposed to sterilization.
The company began the recall on September 4, 2026, and the FDA added it to the Enforcement Report and classified it on October 22, 2026. The recall involved nationwide distribution in Florida, Illinois, North Carolina, Pennsylvania, South Carolina, and Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
restor3d MTP Implant
- Model number
- 1103-161620
- UDI-DI
- 00840097505244
- Lot code
- A02979
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Florida, Illinois, North Carolina, Pennsylvania, South Carolina, and Texas.
- Company
- restor3d Inc.
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99940
- Recall number
- Z-0264-2027
All recalls from restor3d Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
