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
Class II- Recalling firm
- restor3d Inc.
- Reason for recall
- Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
- Affected products (lot / model / serial)
- Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979
- Units affected
- 16
- Distribution pattern
- U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.
- Firm location
- Durham, NC, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0264-2027
- Recall initiated
- September 4, 2026
- FDA classification date
- October 22, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99940
- Last updated on HTM Vibe
- November 3, 2026