Z-2616-2026Class II

Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and...

Name: Z-2616-2026 Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and...
Creator: Depuy (Ireland)
Published: 2026-05-19
License: https://open.fda.gov/license/

Depuy (Ireland) / initiated 2026-05-19 / Open, Classified / root cause: packaging

FDA source

DEPUY (IRELAND) began a recall of Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE... on 2026-05-19. FDA classified it as Class II and gives the reason as "The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2616-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-19
Posted: 2026-06-29
Recalling firm: Depuy (Ireland)
Product: 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.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Reason for recall: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
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.
Quantity in commerce: 66 units
Distribution: Distribution to MN, NC, TX.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2616-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2616-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-29
Z-2617-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-29

Product code KRO

K242871Class IIATTUNE™ Revision Hinge KneeDepuy Ireland UC / cleared 2024-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)