{"url_path":"/fda/device/recalls/Z-2529-2026","section_key":"summary","section_title":"DEVICE Recall: Zimmer, Inc. — Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide  Model/Catalog Number: 110040242","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-20","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2529-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Zimmer, Inc."},"word_count":107,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2529-2026\n\n**Recalling firm:** Zimmer, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-20\n**Report date:** 2026-07-01\n\n## Product\nOff-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide  Model/Catalog Number: 110040242\n\n## Reason\nFive complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.\n\n## Affected lots\nLot Code: Model No. 110040242 ; UDI-DI (01)00889024681989(17)350601(10)099471 ; Lot Number 099471 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350614(10)099473 ; Lot Number 099473 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350804(10)099474 ; Lot Number 099474 Model No. 110040242 ; UDI-DI (01)00889024681989(17)350806(10)099475 ; Lot Number 099475\n\n## Distribution\nUS Nationwide distribution."}