Class IIOngoing
DEPUY (IRELAND) recalls 2 products
Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)
Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.
- Company
- DEPUY (IRELAND)
- Reason
- The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- Hazard
- FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
- Who’s affected
- Distribution to MN, NC, TX.
- Where
- Minnesota, North Carolina, Texas
- Official notice
- www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99078…
Products (2)
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 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.
Codes/lots: 1. 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: 15Quantity: 66 unitsRecall no. Z-2616-2026Class IIDepuy 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.
Codes/lots: 1. 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:Quantity: 160 unitsRecall no. Z-2617-2026Class II
Update history
- First listed on OVERLOOKED from the official record.
When the agency expands or changes this recall, we update this page and log the change here.
Proof: raw official record (JSON) · fetched from FDA API
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