Recall Z-0264-2027 ยท KWD Prosthesis, Toe, Hemi-, Phalangeal
restor3d Inc.
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 dist
| Date | Oct 22, 2026 (initiated Sep 4, 2026) |
| Status | Open, Classified |
| Reason | Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. |
| 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, |
| Quantity | 16 |
| Distribution | U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201393 | restor3d MTP Implant Restor3D, Inc., May 25, 2022 |