DEPUY (IRELAND)
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
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
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.
Data: U.S. FDA. 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. Open the enforcement explorer →