Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number:... recall (restor3d Inc.)
Medical deviceClass IIOngoing
Summary: restor3d Inc. is recalling Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, single-use implant grade metal device, available in varied articulating surface coverages. The r. Reason: Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
What is being recalled
Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, single-use implant grade metal device, available in varied articulating surface coverages. The restor3d MTP implant is designed to replace the damaged articulating surface of the first metatarsal distal head. The device is intended for the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head. This implant can also be used in the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The implant is a single use product intended to be press fit, with optional use of bone cement. The restor3d MTP Implant is comprised of a single laser powder bed fusion (LPBF) printed cobalt-chromium alloy (Co28Cr6Mo) part. The external surface of the implant that is intended to be in contact with the phalanx is mirror polished. Component: Not a component
Why
Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX. (states named: Florida, Illinois, North Carolina, Pennsylvania, South Carolina, Texas)
How to tell if yours is affected
Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0264-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 4, 2026 |
| Reported | October 28, 2026 |
| Company | restor3d Inc. |
| Company location | Durham, NC, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 16 |
More recalls from restor3d Inc. · all medical device recalls · recalls from September 2026