{"url_path":"/fda/device/recalls/Z-2617-2026","section_key":"summary","section_title":"DEVICE Recall: DEPUY (IRELAND) — Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes.    1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410.     2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number: 151730412.     3. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 14mm B; Part Number: 151730414.    …","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-2617-2026%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":955,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2617-2026\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 Insert Components with the below product descriptions and Part Codes.    1. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 10mm B; Part Number: 151730410.     2. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 12mm B; Part Number: 151730412.     3. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 14mm B; Part Number: 151730414.     4. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 16mm B; Part Number: 151730416.     5. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 18mm B; Part Number: 151730418.     6. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 20mm B; Part Number: 151730420.     7. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 22mm B; Part Number: 151730422.     8. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 24mm B; Part Number: 151730424.     9. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 26mm B; Part Number: 151730426.     10. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 4 8mm B; Part Number: 151730408.     11. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 10mm C; Part Number: 151730510.     12. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 12mm C; Part Number: 151730512.     13. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 14mm C; Part Number: 151730514.     14. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 16mm C; Part Number: 151730516.     15. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 18mm C; Part Number: 151730518.     16. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 20mm C; Part Number: 151730520.     17. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 22mm C; Part Number: 151730522.     18. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 24mm C; Part Number: 151730524.     19. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 26mm C; Part Number: 151730526.     20. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 5 8mm C; Part Number: 151730508.     21. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 10mm E; Part Number: 151730710.     22. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 12mm E; Part Number: 151730712.     23. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 14mm E; Part Number: 151730714.     24. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 16mm E; Part Number: 151730716.     25. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 18mm E; Part Number: 151730718.     26. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 20mm E; Part Number: 151730720.     27. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 22mm E; Part Number: 151730722.     28. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 24mm E; Part Number: 151730724.     29. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 26mm E; Part Number: 151730726.     30. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 7 8mm E; Part Number: 151730708.     31. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 10mm W; Part Number: 151730810.     32. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 12mm W; Part Number: 151730812.     33. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 14mm W; Part Number: 151730814.     34. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 16mm W; Part Number: 151730816.     35. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 18mm W; Part Number: 151730818.     36. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 20mm W; Part Number: 151730820.     37. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 22mm W; Part Number: 151730822.     38. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 8mm F; Part Number: 151730808.     39. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 24mm W; Part Number: 151730824.     40. ATTUNE KNEE SYSTEM REVISION HINGE INSERT 8 26mm W; Part Number: 151730826.\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: 151730410. GTIN: 10603295529811. Lot Number: 1007709.   2. Part Number: 151730412. GTIN: 10603295529828. Lot Number: 1007710.   3. Part Number: 151730414. GTIN: 10603295529835. Lot Number: 1005246.   4. Part Number: 151730416. GTIN: 10603295529842. Lot Numbers: 1005247, AF1007712.  5. Part Number: 151730418. GTIN: 10603295529859. Lot Number: 1005248.   6. Part Number: 151730420. GTIN: 10603295529866. Lot Number: AF1008744.   7. Part Number: 151730422. GTIN: 10603295529873. Lot Number: 1007308, AF1007715.   8. Part Number: 151730424. GTIN: 10603295529880. Lot Number: 1005251.   9. Part Number: 151730426. GTIN: 10603295529897. Lot Number: 1007309, AF1009254.   10. Part Number: 151730408. GTIN: 10603295529903. Lot Number: 1005243.   11. Part Number: 151730510. GTIN: 10603295529910. Lot Number: 1008482.   12. Part Number: 151730512. GTIN: 10603295529927. Lot Number: AF1008370.   13. Part Number: 151730514. GTIN: 10603295529934. Lot Number: AF1008371.   14. Part Number: 151730516. GTIN: 10603295529941. Lot Number: AF1008372.   15. Part Number: 151730518. GTIN: 10603295529958. Lot Number: 1007067.   16. Part Number: 151730520. GTIN: 10603295529965. Lot Number: 1005343, 1008374.  17. Part Number: 151730522. GTIN: 10603295529972. Lot Number: 1005259.   18. Part Number: 151730524. GTIN: 10603295529989. Lot Number: 1008376.   19. Part Number: 151730526. GTIN: 10603295529996. Lot Number: 1005261, AF1008658.   20. Part Number: 151730508. GTIN: 10603295530008. Lot Number: 1005253.   21. Part Number: 151730710. GTIN: 10603295530015. Lot Number: AF1008379.   22. Part Number: 151730712. GTIN: 10603295530022. Lot Number: AF1008714.   23. Part Number: 151730714. GTIN: 10603295530039. Lot Number: 1005265.   24. Part Number: 151730716. GTIN: 10603295530046. Lot Number: AF1008720.   25. Part Number: 151730718. GTIN: 10603295530053. Lot Number: 1005267  26. Part Number: 151730720. GTIN: 10603295530060. Lot Number: 1005268.   27. Part Number: 151730722. GTIN: 10603295530077. Lot Number: AF1005625.   28. Part Number: 151730724. GTIN: 10603295530084. Lot Number: 1005270.   29. Part Number: 151730726. GTIN: 10603295530091. Lot Number: AF1008385.   30. Part Number: 151730708. GTIN: 10603295530107. Lot Number: 1005262.   31. Part Number: 151730810. GTIN: 10603295544289. Lot Number: AF1008387.   32. Part Number: 151730812. GTIN: 10603295544296. Lot Number: 1005274, 1008388.   33. Part Number: 151730814. GTIN: 10603295544203. Lot Number: 1007691.   34. Part Number: 151730816. GTIN: 10603295544210. Lot Number: 1007692.   35. Part Number: 151730818. GTIN: 10603295544227. Lot Number: 1005277.   36. Part Number: 151730820. GTIN: 10603295544234. Lot Number: AF1007694.   37. Part Number: 151730822. GTIN: 10603295544241. Lot Number: 1005279.   38. Part Number: 151730808. GTIN: 10603295544272. Lot Number: 1005272.   39. Part Number: 151730824. GTIN: 10603295544258. Lot Number: 1007696.   40. Part Number: 151730826. GTIN: 10603295544265. Lot Number: 1007697.\n\n## Distribution\nDistribution to MN, NC, TX."}