CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report
Depuy Synthes, Attune Revision Hinge Knee Hinge Housing recalled
Depuy (Ireland) is recalling Depuy Synthes, Attune Revision Hinge Knee Hinge Housing Components with the below product, distributed in Minnesota, North Carolina, Texas. The recall was initiated on 19 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2616-2026
- FDA event ID
- 99078
- Recalling firm
- Depuy (Ireland), Co. Cork, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 May 2026
- FDA classified
- 29 Jun 2026
- Reported
- 8 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 19 May 2026 | Recall initiated by company | |
| 29 Jun 2026 | Classified by FDA | +41 days |
| 8 Jul 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Distribution to MN, NC, TX.
Questions about this recall
Why was it recalled?
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Which lots are affected?
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.
Where was it sold?
Distribution to MN, NC, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99078This product is part of a recall event; the main page for the event is Depuy Synthes, Attune Revision Hinge Knee Hinge Insert recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Depuy Synthes, Attune Revision Hinge Knee Hinge Insert recalled | Depuy (Ireland) | Sterility | MN, NC, TX |
More recalls from Depuy (Ireland)
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Depuy Synthes, Attune Revision Hinge Knee Hinge Insert recalled | Depuy (Ireland) | Sterility | MN, NC, TX |
| Device | CLASS II | Depuy Synthes, Attune Revision Hinge Femoral RT SZ 4 Cem recalled | Depuy (Ireland) | Sterility | Nationwide |
| Device | CLASS II | Depuy Synthes, Attune Revision Hinge Femoral LT SZ 4 Cem recalled | Depuy (Ireland) | Sterility | Nationwide |
| Device | CLASS II | Depuy Synthes, Attune Revision Hinge Femoral RT SZ 7 Cem recalled | Depuy (Ireland) | Sterility | Nationwide |
| Device | CLASS II | Depuy Synthes, Attune Revision Hinge Femoral RT SZ 3 Cem recalled | Depuy (Ireland) | Sterility | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |