Depuy (Ireland)
CO. CORK Munster, IE
DEPUY (IRELAND) appears in FDA device records in CO. CORK Munster, IE. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Depuy (Ireland) between 2010 and 2022. The busiest year on record is 2019, with 4. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2019 | 4 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K212683 | GLOBAL ICON Stemless Shoulder System | PKC | Substantially Equivalent | |
| K192855 | DELTA XTEND(TM) Reverse Shoulder System | PHX | Substantially Equivalent | |
| K190344 | DePuy Corail AMT Hip Prosthesis | LZO | Substantially Equivalent | |
| K191779 | Attune Revision LPS Inserts | KRO | Substantially Equivalent | |
| K192448 | Delta Xtend Revers Shoulder System | PHX | Substantially Equivalent | |
| K183077 | Delta Xtend Reverse Shoulder System | PHX | Substantially Equivalent | |
| K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | JWH | Substantially Equivalent | |
| K160907 | DePuy Actis DuoFix Hip Prosthesis | MEH | Substantially Equivalent | |
| K160700 | ATTUNE Revision Knee System | JWH | Substantially Equivalent | |
| K140881 | DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS | MBH | Substantially Equivalent | |
| K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | KWS | Substantially Equivalent | |
| K101996 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | PHX | Substantially Equivalent | |
| K102080 | DEPUY RECLAIM REVISION HIP SYSTEM | LZO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9616671 | 3002854251 | DEPUY (IRELAND) | LOUGHBEG, CO. CORK Munster -- IE | 2026 | and 65 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- HWJAwl
- HTWBit, Drill
- LODBone Cement
- HTQBroach
- KTZCaliper
- FZOChisel, Surgical, Manual
- HXDClamp
- HTFCurette
- HXZCutter, Wire
- KIHDispenser, Cement
- HWRDriver, Prosthesis
- JDYEvacuator, Vapor, Cement Monomer
- HWBExtractor
- HTPFile
- GENForceps, General & Plastic Surgery
- HYAForceps, Wire Holding
- HTJGauge, Depth
- KQWGoniometer, Nonpowered
- GDHGouge, Surgical, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- KIKHook, Bone
- HWAImpactor
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- GFJMallet, Surgical, General & Plastic Surgery
- JDZMixer, Cement, For Clinical Use
- HWMOsteotome
- HXIPasser, Wire, Orthopedic
- HTCPliers, Surgical
- JDBProsthesis, Elbow, Semi-Constrained, Cemented
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HXOPusher, Socket
- HTRRasp
- HTOReamer
- GADRetractor
- HTXRongeur
- HSOSaw
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- HXGTamp
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2617-2026 | 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. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified | |
| Z-2616-2026 | 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. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified | |
| Z-1993-2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified | |
| Z-1992-2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified | |
| Z-1991-2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified | |
| Z-1990-2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified | |
| Z-1989-2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified | |
| Z-1988-2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified | |
| Z-1987-2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified | |
| Z-1986-2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified | |
| Z-1985-2026 | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain