Z-0264-2027Class II

Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software...

Name: Z-0264-2027 Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software...
Creator: restor3d Inc.
Published: 2026-09-04
License: https://open.fda.gov/license/

restor3d Inc. / initiated 2026-09-04 / Open, Classified

FDA source

Recall record

Recall number: Z-0264-2027
Classification: Class II
Status: Open, Classified
Initiated: 2026-09-04
Posted: 2026-10-22
Recalling firm: 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
Product code: KWD Prosthesis, Toe, Hemi-, Phalangeal
Reason for recall: Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
FDA root cause: Process change control
Action: On 09/21/2026, an "URGENT: MEDICAL DEVICE VOLUNTARY RECALL" Letter was emailed to customers informing them that, Restor3d has identified an error in the sterilization of a lot of large MTP implants (part number 1103-161620) were found in the field with orange sterilization indicators, rather than red, when orange indicates not exposed to sterilization and red indicates exposed to sterilization. Root cause investigation to date indicates that the lot was never sterilized. Customers are instructed to: Do not implant or otherwise use any affected units identified above. Quarantine all affected, unused units identified above and remove them from implant sets, consignment inventory, inventory shelves, and any other storage locations. Complete the attached Field Action Response Form (Attachment A) and return it to restor3d within 10 business days, whether or not affected product is in your possession, so that restor3d can confirm effective distribution of this notice. Package the affected MTP Implants (1103-161620; A02979) to return to restor3d. restor3d has provided a prepaid FedEx shipping label by email for shipment back to 4001 NC-54 Hwy, Suite 2160 Durham, NC 27709. Promptly report to restor3d any patient adverse event, suspected device-related complication, revision surgery, or other clinical concern potentially associated with the affected product. For questions or further assistance - contact Restor3d can be reached at 984-888-0593 or at [email protected].
Quantity in commerce: 16
Distribution: U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.
Product codes and lots: Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0264-2027
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0264-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-28	2026-10-22

Product code KWD

K201393Class IIrestor3d MTP ImplantRestor3D, Inc. / cleared 2022-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-10-30. View this recall on fda.gov (opens on fda.gov)