| | Class 2 Device Recall Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components |  |
| Date Initiated by Firm | May 19, 2026 |
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| Date Posted | June 29, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2617-2026 |
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| Recall Event ID |
99078 |
| 510(K)Number | K242871 |
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| Product Classification |
Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
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| 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. |
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| Code Information |
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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| FEI Number |
3002854251
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Recalling Firm/
Manufacturer |
DEPUY (IRELAND)
Loughbeg, Ringaskiddy
Co. Cork Ireland
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| For Additional Information Contact | Kimberly Long
574-221-8156 |
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Manufacturer Reason
for Recall | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | DePuy Synthes notified consignees on about 0519/2026 via email. Consignees were instructed to examine inventory and quarantine any affected units on hand, contact the DePuy Sunthes Sales Consultant or customer support to coordinate the return of affected units, complete and return the Business Response Form, forward the notification to anyone in each facility that needs to be informed, and if any of the affected units have been sold or transferred to contact that facility and provide the notification. Consignees were also requested to post a copy of the notification in a visible area for awareness and keep a copy for your records. |
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| Quantity in Commerce | 160 units |
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| Distribution | Distribution to MN, NC, TX. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = KRO
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