Depuy Ireland UC
FDA Regulatory Profile
Depuy Ireland UC appears in FDA public data with 1 recall, 50 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0951-2023, Class II) was initiated on December 19, 2022. Its most recent 510(k) clearance was granted on June 25, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 50
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0951-2023 | Class II | BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10 | December 19, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | June 25, 2026 |
| K260480 | VELYS Robotic-Assisted Solution | June 25, 2026 |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | May 15, 2026 |
| K253624 | INHANCE Reverse Shoulder System | March 11, 2026 |
| K253551 | VELYS Hip Navigation | March 6, 2026 |
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | November 19, 2025 |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | May 23, 2025 |
| K243977 | EMPHASYS Acetabular System | January 22, 2025 |
| K243248 | INHANCE INTACT | December 23, 2024 |
| K242871 | ATTUNE Revision Hinge Knee | November 21, 2024 |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | October 7, 2024 |
| K241000 | ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal | July 11, 2024 |
| K240678 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella wi | June 18, 2024 |
| K240211 | VELYS Robotic-Assisted Solution | June 5, 2024 |
| K240639 | PINNACLETM Constrained Acetabular Liners | April 4, 2024 |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Pe | March 21, 2024 |
| K231522 | EMPHASYS Dual Mobility System | February 15, 2024 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Condi | January 19, 2024 |
| K231526 | CORAIL Cemented Femoral Stem | December 19, 2023 |
| K233227 | VELYS Robotic-Assisted Solution | December 14, 2023 |