Class II recallOngoing
DePuy Synthes ATTUNE Knee System recall — FDA event 99078
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
FDA · FDA event 99078Posted Jun 29, 2026
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Total knee replacement system
2 ongoing recall records reference this device, out of 2 total records tracked.
Source checks below cover individual records. A manufacturer product-page check confirms device identity; it does not confirm recall status.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
| Model | Description | Lot / serial range | Manufactured | Status |
|---|---|---|---|---|
| Z-2616-2026 | Z-2616-2026 | 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: 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. | Not provided in the normalized record | Ongoing |
| Z-2617-2026 | Z-2617-2026 | 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. | Not provided in the normalized record | Ongoing |
| Z-1985-2026 | Z-1985-2026 | Part Number: 150450104. UDI-DI: 10603295533115. Lot Number: 1007844. Expiration Date: 11/30/2035 | Not provided in the normalized record | Ongoing |
| Z-1993-2026 | Z-1993-2026 | Part Number: 150450208. UDI-DI: 10603295543039. Lot Numbers: AF1008441, AF1008028. Expiration Date: 12/31/2035. | Not provided in the normalized record | Ongoing |
| Z-1986-2026 | Z-1986-2026 | Part Number: 150450105. UDI-DI: 10603295533122. Lot Number: AF1007829. Expiration Date: 12/31/2035. | Not provided in the normalized record | Ongoing |
| Z-1992-2026 | Z-1992-2026 | Part Number: 150450207. UDI-DI: 10603295533177. Lot Number: 1007046. Expiration Date: 10/31/2035. | Not provided in the normalized record | Ongoing |
| Z-1991-2026 | Z-1991-2026 | Part Number: 150450205. UDI-DI: 10603295533160. Lot Number: 1006444. Expiration Date: 10/31/2035. | Not provided in the normalized record | Ongoing |
| Z-1990-2026 | Z-1990-2026 | Part Number: 150450204. UDI-DI: 10603295533153. Lot Number: 1005229. Expiration Date: 10/31/2035. | Not provided in the normalized record | Ongoing |
| Z-1988-2026 | Z-1988-2026 | Part Number: 150450108. UDI-DI: 10603295543022. Lot Number: AF1006441. Expiration Date: 12/31/2035. | Not provided in the normalized record | Ongoing |
| Z-1987-2026 | Z-1987-2026 | Part Number: 150450107. UDI-DI: 10603295533139. Lot Number: 1006440. Expiration Date: 11/30/2035. | Not provided in the normalized record | Ongoing |
| Z-1989-2026 | Z-1989-2026 | Part Number: 150450203. UDI-DI: 10603295533146. Lot Number: 1007537. Expiration Date: 10/31/2035. | Not provided in the normalized record | Ongoing |