Device recall
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
- Recall number
- Z-0264-2027
- Event id
- 99940
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- restor3d Inc.
- Report date
- Oct 28, 2026
- Posted
- Oct 22, 2026
- Initiated
- Sep 4, 2026
- Center classification date
- Oct 22, 2026
- Product code
- KWD
- Device type
- Prosthesis, Toe, Hemi-, Phalangeal
- Reason
- Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
- Root cause
- Process change control
- Quantity
- 16
- Code info
- Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979
- Distribution
- U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K201393
- Location
- Durham, NC, United States