{"url_path":"/fda/device/recalls/Z-2616-2026","section_key":"summary","section_title":"DEVICE Recall: DEPUY (IRELAND) — Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes.    1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010.     2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN C; Part Number: 151730012.     3. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING C…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-19","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2616-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"DEPUY (IRELAND)"},"word_count":579,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2616-2026\n\n**Recalling firm:** DEPUY (IRELAND)\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-19\n**Report date:** 2026-07-08\n\n## Product\nDepuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes.    1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010.     2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN C; Part Number: 151730012.     3. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN D; Part Number: 151730014.     4. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN E; Part Number: 151730016.     5. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN F; Part Number: 151730018.     6. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN G; Part Number: 151730020.     7. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN H; Part Number: 151730022.     8. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN I; Part Number: 151730024.     9. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN J; Part Number: 151730026.     10. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN K; Part Number: 151730028.     11. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN L; Part Number: 151730030.     12. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN M; Part Number: 151730032.     13. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN N; Part Number: 151730034.     14. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN P; Part Number: 151730038.     15. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN Q; Part Number: 151730040.     16. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN R; Part Number: 151730042.     17. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN S; Part Number: 151730044.     18. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN T; Part Number: 151730046.     19. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN U; Part Number: 151730048.     20. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN V; Part Number: 151730050.     21. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN W; Part Number: 151730052.     22. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN X; Part Number: 151730036.\n\n## Reason\nThe external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.\n\n## Affected lots\n1. Part Number: 151730010. GTIN: 10603295534075. Lot Number: AF1007816.  2. Part Number: 151730012. GTIN: 10603295534082. Lot Number: AF1007817.   3. Part Number: 151730014. GTIN: 10603295534099. Lot Number: AF1007819.   4. Part Number: 151730016. GTIN: 10603295534105. Lot Number: 1005405.   5. Part Number: 151730018. GTIN: 10603295534112. Lot Number: AF1007823.   6. Part Number: 151730020. GTIN: 10603295534129. Lot Numbers: 1005407, AF1007983.   7. Part Number: 151730022. GTIN: 10603295534136. Lot Number: AF1007984.   8. Part Number: 151730024. GTIN: 10603295534143. Lot Number: 1005409.   9. Part Number: 151730026. GTIN: 10603295534150. Lot Number: 1005410.   10. Part Number: 151730028. GTIN: 10603295550518. Lot Number: AF1007227.  11. Part Number: 151730030. GTIN: 10603295550525. Lot Number: 1005412.   12. Part Number: 151730032. GTIN: 10603295550532. Lot Number: 1005413.   13. Part Number: 151730034. GTIN: 10603295550549. Lot Number: 1005414.   14. Part Number: 151730038. GTIN: 10603295550563. Lot Numbers: AF1007231, AF1007980.   15. Part Number: 151730040. GTIN: 10603295550570. Lot Number: 1005417.   16. Part Number: 151730042. GTIN: 10603295550587. Lot Number: AF1007234.   17. Part Number: 151730044. GTIN: 10603295550594. Lot Number: AF1007977.   18. Part Number: 151730046. GTIN: 10603295550600. Lot Number: AF1007289.   19. Part Number: 151730048. GTIN: 10603295550617. Lot Number: AF1007290.   20. Part Number: 151730050. GTIN: 10603295550624. Lot Numbers: 1005422, AF1007333, AF1008548.    21. Part Number: 151730052. GTIN: 10603295550631. Lot Number: AF1008267.   22. Part Number: 151730036. GTIN: 10603295550556. Lot Number: 1005415.\n\n## Distribution\nDistribution to MN, NC, TX."}