{"url_path":"/fda/device/recalls/Z-2050-2026","section_key":"summary","section_title":"DEVICE Recall: Centinel Spine, Inc. — Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5    Total cervical disc replacement.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-20","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2050-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Centinel Spine, Inc."},"word_count":104,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2050-2026\n\n**Recalling firm:** Centinel Spine, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-20\n**Report date:** 2026-05-13\n\n## Product\nProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5    Total cervical disc replacement.\n\n## Reason\nProduct labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.\n\n## Affected lots\nModel Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026\n\n## Distribution\nUS Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX."}