restor3d Inc. recalls Generic Name: restor3d MTP Implant Generic Name: MTP Implant

Recalling company

restor3d Inc.

Product

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

Reason

Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 4, 2026

Reported

Oct 28, 2026

Distribution

U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.

Status

Ongoing

Quantity

16

Lot / codes

Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979

Company location

Durham, NC

Recall type

Voluntary: Firm initiated

Recall number

Z-0264-2027

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0264-2027 in the FDA Enforcement Report. Also see FDA recall press releases.