FDA Medical devices recall ·
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the… recall
- Recall number
- Z-2617-2026
- Date
- (initiated May 19, 2026)
- Company / brand
- Depuy (Ireland)
Loughbeg, Ringaskiddy, Co. Cork, N/A, Ireland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 160 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 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.
Why was it recalled?
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
Distribution
Distribution to MN, NC, TX.
States: Minnesota North Carolina Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2617-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.