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U.S. Department of Health and Human Services

Class 2 Device Recall restor3d MTP Implant

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 Class 2 Device Recall restor3d MTP Implantsee related information
Date Initiated by FirmSeptember 04, 2026
Date PostedOctober 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0264-2027
Recall Event ID 99940
510(K)NumberK201393 
Product Classification Prosthesis, toe, hemi-, phalangeal - Product Code KWD
ProductGeneric 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
Code Information Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979
FEI Number 3014833750
Recalling Firm/
Manufacturer		 restor3d Inc.
4001 E Nc 54 Hwy
Suite 3160
Durham NC 27709
For Additional Information ContactBrianna Gabbard
1-786-5210501
Manufacturer Reason
for Recall		Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
FDA Determined
Cause 2		Process change control
ActionOn 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 complaints@restor3d.com.
Quantity in Commerce16
DistributionU.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KWD
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