{"url_path":"/fda/device/recalls/Z-2758-2026","section_key":"summary","section_title":"DEVICE Recall: Paragon 28, Inc. — P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-17","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2758-2026%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":113,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2758-2026\n\n**Recalling firm:** Paragon 28, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-17\n**Report date:** 2026-07-29\n\n## Product\nP28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.\n\n## Reason\nParagon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.\n\n## Affected lots\nUDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225;  UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225;  UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725;  UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925;  UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.\n\n## Distribution\nUS nationwide, Australia, Canada, The Netherlands, and New Zealand"}