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Z-2617-2026Class II

DEPUY (IRELAND)

Recalling firm
DEPUY (IRELAND)
Product type
Device
Status
Ongoing
Report date
2026-07-08
Distribution
Distribution to MN, NC, TX.
Firm state
N/A
Product quantity
160 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

Product description

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. 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 Numb

Code / lot info

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: 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.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.