# Class II recall Z-0264-2027: restor3d Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0264-2027 |
| Recalling firm | restor3d Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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 f |
| Reason | Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. |
| Quantity | 16 |
| Distribution | U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX. |
| Recall initiated | 2026-09-04 |
| Reported | 2026-10-28 |
| Firm location | Durham, NC, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 7 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0264-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.