Class II Recall

Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None

Summary

The FDA issued a Class II for Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Num by restor3d Inc.. Reason: Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization..

Details

Source

Device Recall

External ID

Z-0264-2027

Action Date

2026-10-28

Status

Ongoing

Product Description

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

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

Quantity Affected: 16

Reason for Recall

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

Distribution

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

Type: Voluntary: Firm initiated

Recall Initiated: 2026-09-04

Company

restor3d Inc.

Durham, NC

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.

restor3d Inc. has 12 FDA actions in our database, including 6 recalls and 6 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (restor3d Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does restor3d Inc. have FDA actions?

restor3d Inc. has 12 FDA actions in our database, including 6 recalls and 6 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0264-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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