ATTUNE recallZ-2616-2026 · Depuy (Ireland) · initiated May 19, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Depuy (Ireland) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2616-2026
- Status
- Open, Classified
- Initiated by the company
- May 19, 2026
- Posted by the FDA
- Jun 29, 2026
- Recalling firm
- Depuy (Ireland)
- Quantity
- 66 units
- Product code
- KRO
- FDA submissions
- K242871
- Distribution
- Distribution to MN, NC, TX.
Product description
Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010. 2. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN C; Part Number: 151730012. 3. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN D; Part Number: 151730014. 4. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN E; Part Number: 151730016. 5. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN F; Part Number: 151730018. 6. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN G; Part Number: 151730020. 7. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN H; Part Number: 151730022. 8. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN I; Part Number: 151730024. 9. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN J; Part Number: 151730026. 10. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN K; Part Number: 151730028. 11. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN L; Part Number: 151730030. 12. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN M; Part Number: 151730032. 13. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN N; Part Number: 151730034. 14. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN P; Part Number: 151730038. 15. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN Q; Part Number: 151730040. 16. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN R; Part Number: 151730042. 17. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN S; Part Number: 151730044. 18. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN T; Part Number: 151730046. 19. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN U; Part Number: 151730048. 20. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN V; Part Number: 151730050. 21. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN W; Part Number: 151730052. 22. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN X; Part Number: 151730036.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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.
Devices named in this recall
22 devices in the FDA device registry whose identifier appears in the recall's code information.
- ATTUNE 1517-30-010Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-012Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-014Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-016Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-018Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-020Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-022Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-024Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-026Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-028Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-030Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-032Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-034Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-036Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-038Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-040Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-042Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-044Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-046Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-048Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-050Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- ATTUNE 1517-30-052Depuy (Ireland) · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99078).
- Z-2617-2026 · Open, ClassifiedDepuy 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 Nu…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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