{"url_path":"/fda/device/recalls/Z-2532-2026","section_key":"summary","section_title":"DEVICE Recall: Acumed LLC — Acumed Hexalob Screw various sizes:  REF Numbers: : 3070-27008\t2.7mm x 8mm NL Hexalobe Screw;  3070-27009\t2.7mm x 9mm NL Hexalobe Screw;  3070-27010\t2.7mm x 10mm NL Hexalobe Screw;  3070-27011\t2.7mm x 11mm NL Hexalobe Screw;  3070-27012\t2.7mm x 12mm NL Hexalobe Screw;  3070-27013\t2.7mm x 13mm NL Hexalobe Screw;  3070-27014\t2.7mm x 14mm NL Hexalobe Screw;  3070-27015\t2.…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-28","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2532-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Acumed LLC"},"word_count":241,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2532-2026\n\n**Recalling firm:** Acumed LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-28\n**Report date:** 2026-07-01\n\n## Product\nAcumed Hexalob Screw various sizes:  REF Numbers: : 3070-27008\t2.7mm x 8mm NL Hexalobe Screw;  3070-27009\t2.7mm x 9mm NL Hexalobe Screw;  3070-27010\t2.7mm x 10mm NL Hexalobe Screw;  3070-27011\t2.7mm x 11mm NL Hexalobe Screw;  3070-27012\t2.7mm x 12mm NL Hexalobe Screw;  3070-27013\t2.7mm x 13mm NL Hexalobe Screw;  3070-27014\t2.7mm x 14mm NL Hexalobe Screw;  3070-27015\t2.7mm x 15mm NL Hexalobe Screw;  3070-27016\t2.7mm x 16mm NL Hexalobe Screw;  3070-27017\t2.7mm x 17mm NL Hexalobe Screw;  3070-27018\t2.7mm x 18mm NL Hexalobe Screw;  3076-30010\t3.0mm x 10mm NL Hexalobe Screw;  3076-30012\t3.0mm x 12mm NL Hexalobe Screw;  3076-30014\t3.0mm x 14mm NL Hexalobe Screw\n\n## Reason\nDue to manufacturing error, hexalobe screws used with wrist fixation system may break during use.\n\n## Affected lots\n3070-27008/Lots: 668261/UDI: 10806378125997; 3070-27009/Lots: 680797/UDI: 10806378126000; 3070-27010/Lots: 667231, 682194/UDI: 10806378126017; 3070-27011/Lots: 680621, 680737/UDI: 10806378126024; 3070-27012/Lots: 667233, 668266, 668704, 682195/UDI: 10806378126031; 3070-27013/Lots:668706, 680400/UDI: 10806378126048; 3070-27014/Lots: 667236, 668705, 680935/UDI: 10806378126055; 3070-27015/Lots: 667237, 680936/UDI: 10806378126062; 3070-27016/Lots: 668269, 682390/UDI: 10806378126079; 3070-27017/Lot: 681575/UDI: 10806378126086; 3070-27018/Lot: 667169, 668260, 682482/UDI: 10806378126093; 3076-30010/Lots: 667202, 668271/UDI: 10806378126109; 3076-30012/Lots: 667242, 668273/UDI: 10806378126116; 3076-30014/Lots: 667205, 668272/UDI: 10806378126123\n\n## Distribution\nUS Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MS, NC, \tNM, NY, OH, OK, OR, PA, SC, TN, TX, UT, WA, WI."}