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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DePuy Synthes · Knee implants · Model family DePuy Synthes ATTUNE Knee System
Total knee replacement system
2 ongoing recall records reference this device, out of 2 total records tracked.
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-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-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-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-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-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-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-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 |
| 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-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-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-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 |