DePuy Orthopaedics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 155 (5 Class I)
- 510(k) Clearances
- 208
- Inspections
- 11
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1456-2024 | Class II | ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE T | March 12, 2024 |
| Z-1263-2023 | Class II | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118 | February 15, 2023 |
| Z-1264-2023 | Class II | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212 | February 15, 2023 |
| Z-1267-2023 | Class II | Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507 | February 15, 2023 |
| Z-1265-2023 | Class II | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226 | February 15, 2023 |
| Z-1266-2023 | Class II | Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312 | February 15, 2023 |
| Z-1419-2022 | Class II | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in p | June 29, 2022 |
| Z-1375-2022 | Class II | MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthe | May 18, 2022 |
| Z-1029-2022 | Class II | VELYS Robotic-Assisted Solution Base Product No.: 451570100 | March 11, 2022 |
| Z-0632-2022 | Class II | ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty | January 5, 2022 |
| Z-0631-2022 | Class II | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthropl | January 5, 2022 |
| Z-0488-2022 | Class II | GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100 | December 7, 2021 |
| Z-0485-2022 | Class II | GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600 | December 7, 2021 |
| Z-0486-2022 | Class II | GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100 | December 7, 2021 |
| Z-0483-2022 | Class II | GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 | December 7, 2021 |
| Z-0489-2022 | Class II | GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100 | December 7, 2021 |
| Z-0487-2022 | Class II | GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 | December 7, 2021 |
| Z-0484-2022 | Class II | GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100 | December 7, 2021 |
| Z-0490-2022 | Class II | GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100 | December 7, 2021 |
| Z-0074-2022 | Class II | ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:15230700 | September 9, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231503 | CUPTIMIZE Advanced | August 22, 2023 |
| K213839 | DePuy Corail AMT Hip Prosthesis | January 6, 2022 |
| K210167 | DELTA XTEND Reverse Shoulder System | February 19, 2021 |
| K203167 | DePuy Corail AMT Hip Prosthesis | November 19, 2020 |
| K202472 | ACTIS Duofix Hip Prosthesis | October 21, 2020 |
| K201347 | DePuy ATTUNE Total Knee System | June 18, 2020 |
| K193540 | TRUMATCH Personalized Solutions | June 16, 2020 |
| K193398 | Summit DuoFix HA Coating | February 4, 2020 |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | November 26, 2019 |
| K192946 | DePuy Corail AMT Hip Prosthesis | November 26, 2019 |
| K182301 | PFC SIGMA Knee System | November 8, 2019 |
| K170339 | Summit Hip System | April 26, 2018 |
| K150862 | DePuy Actis Duofox Hip Prosthesis | September 25, 2015 |
| K132959 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | March 10, 2014 |
| K120599 | DEPUY M-SPEC 36MM FEMORAL HEADS | April 30, 2013 |
| K123924 | DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS | March 1, 2013 |
| K122395 | DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS | October 31, 2012 |
| K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | March 12, 2012 |
| K112218 | ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS | December 15, 2011 |
| K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM | August 30, 2011 |