{"url_path":"/fda/device/recalls/Z-2971-2026","section_key":"summary","section_title":"DEVICE Recall: Paragon 28, Inc. — Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-10","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2971-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Paragon 28, Inc."},"word_count":85,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2971-2026\n\n**Recalling firm:** Paragon 28, Inc.\n**Classification:** Class III\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-10\n**Report date:** 2026-08-26\n\n## Product\nCustom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant\n\n## Reason\nDevice was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.\n\n## Affected lots\nLot Number AOCIA6123\n\n## Distribution\nUS Nationwide distribution i the state of MT."}