Instruments Designed For Press-fit Osteochondral Implants
Orthopedic · 21 CFR 888.4505
The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.
Recent MDR events
102 adverse event reports on file
- ACTIS BROACH SIZE 6Jun 19, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-10535
- EMPHASYSJun 18, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-10444
- ACTISMay 29, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-09400
- ACTISMay 22, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-09137
- ACTISMay 11, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-08547
- ACTIS BROACH SIZE 6Mar 18, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-04936
- ACTIS BROACH SIZE 4Mar 18, 2026MalfunctionDepuy Ireland - 30155162661818910-2026-04935
- ACTIS BROACH SIZE 11Mar 13, 2026MalfunctionDepuy Ireland1818910-2026-04757
- ACTIS BROACH SIZE 12Mar 13, 2026MalfunctionDepuy Ireland1818910-2026-04763
- ACTIS BROACH SIZE 9Mar 13, 2026MalfunctionDepuy Ireland1818910-2026-04777
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
15 firms currently registered for this product code
Depuy Ireland Uc
Co. Cork Munster, IE
Cartiheal Ltd.
Kfar Saba Central, IL
Li Wai Precision International Limited
Tsimshatsui, Kowloon, HK
Paragon Medical, Inc.
PIERCETON, IN, US
Guangzhou Aquila Precise Tools Limited
Guangzhou City Guangdong, CN
Swami Medical
Del Mar, CA, US
Sor Van Radiation Ltd
Yavne Tel Aviv, IL
Depuy Orthopaedics, Inc.
WARSAW, IN, US
Musculoskeletal Transplant Foundation D/b/a/ Mtf Biologics
Olyphant, PA, US
Musculoskeletal Transplant Foundation D/b/a/ Mtf Biologics
EDISON, NJ, US
Depuy Intl., Ltd.
LEEDS, GB
T.a.g. Medical Products Corporation Ltd
GAATON Northern, IL
Musculoskeletal Transplant Foundation D/b/a/ Mtf Biologics
JESSUP, PA, US
Skeletal Dynamics, Inc
Miami, FL, US
Depuy (ireland)
CO. CORK Munster, IE
510(k) clearances
2 clearances for this product code