{"url_path":"/fda/device/recalls/Z-2958-2026","section_key":"summary","section_title":"DEVICE Recall: Arrowhead DE LLC — Arrow-LOK Implant, REF:  21-253519,  21-253522,  21-253525,  21-253528,  21-253530,  21-253533,  21-253535,  21-253540,  21-253545,  21-253550,  21-353513,  21-353516,  27-253519,  27-253522,  27-253525,  27-253528,  27-253530,  27-253533,  27-253535.  Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corre…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-23","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2958-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Arrowhead DE LLC"},"word_count":144,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2958-2026\n\n**Recalling firm:** Arrowhead DE LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-23\n**Report date:** 2026-08-26\n\n## Product\nArrow-LOK Implant, REF:  21-253519,  21-253522,  21-253525,  21-253528,  21-253530,  21-253533,  21-253535,  21-253540,  21-253545,  21-253550,  21-353513,  21-353516,  27-253519,  27-253522,  27-253525,  27-253528,  27-253530,  27-253533,  27-253535.  Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures.\n\n## Reason\nImplant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.\n\n## Affected lots\nREF/UDI-DI/Lot: 21-253519/00855967006035/24662119, 242162;  21-253522/00855967006042/24662122, 242163, 220702;  21-253525/00855967006059/24662125, 220703, 242164;  21-253528/00855967006066/24662128, 242165, 230704;  21-253530/00855967006073/242166, 230705, 220705;  21-253533/00855967006080/24662133, 242167, 230706;  21-253535/00855967006097/24662135, 242168, 230707;  21-253540/00855967006110/242169;  21-253545/00855967006127/242170;  21-253550/00855967006134/24662150;  21-353513/00855967006004/24662113, 242160;  21-353516/00855967006011/24662116, 230701, 242161;  27-253519/00855967006028/24662719, 242171;  27-253522/00855967006141/242172;  27-253525/00855967006158/242173;  27-253528/00855967006165/242174;  27-253530/00855967006172/242175;  27-253533/00855967006189/24662733, 242176;  27-253535/00855967006196/24662735, 242177\n\n## Distribution\nUS Nationwide distribution in the states of VT, FL, TN, NY, GA, TX, HI."}