{"recall":{"id":"fda-device-99940","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"restor3d Inc. recalls Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Versio","firm":"restor3d Inc.","date":"2026-09-04","reported":"2026-10-28","status":"Ongoing","classification":"Class II","products":[{"name":"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","code":"Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979","quantity":"16","number":"Z-0264-2027","classification":"Class II"}],"reason":"Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.","nationwide":true,"states":[],"units":"16","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99940","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7acacb5f8042df2d","firstSeen":"2026-11-02T22:17:07.772Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99940","record":[{"status":"Ongoing","city":"Durham","state":"NC","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99940","recalling_firm":"restor3d Inc.","address_1":"4001 E Nc 54 Hwy","address_2":"Suite 3160","postal_code":"27709","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.","recall_number":"Z-0264-2027","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","product_quantity":"16","reason_for_recall":"Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.","recall_initiation_date":"20260904","center_classification_date":"20261022","report_date":"20261028","code_info":"Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979","more_code_info":""}]}}