Home › Device types › JDI
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
FDA product code JDI · Class 2 · Orthopedic
0
Registered devices
70,757
Adverse events
255
Recalls
565
510(k) clearances
Devices with this code
Encompass Hip Stem — Ortho Development CorporationTAPERLOC COMPLETE RASP/PROVISIONAL — Biomet Orthopedics, LLCArcos Modular Revision Hip System — Biomet Orthopedics, LLCEcho® Press-Fit Hip System — Biomet Orthopedics, LLCPROFEMUR® — Microport Orthopedics Inc.REFLECTION — Smith & Nephew, Inc.Arcos® Revision Hip Instrumentation — Biomet Uk LtdTrident — Howmedica Osteonics Corp.Modulus Hip System — LIMACORPORATE SPAOSS™ Orthopedic Salvage System — Biomet Orthopedics, LLCASPHERE — DEPUY (IRELAND)PINNACLE GRIPTION — DEPUY ORTHOPAEDICS, INC.Continuum® Trabecular Metal™ — Zimmer, Inc.Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KGINSTRUMENT — Howmedica Osteonics Corp.Continuum® Trilogy® Allofit® Longevity® — Zimmer, Inc.NA — Zimmer, Inc.RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, LLCAvenir® Müller — Zimmer GmbHWagner Cone Prosthesis® — Zimmer GmbHEXETER — Howmedica Osteonics Corp.Trident — Howmedica Osteonics Corp.SL-PLUS — Smith & Nephew, Inc.PROFEMUR® — Microport Orthopedics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-09 | BioPro, Inc. | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infectio |
| 2025-08-28 | Howmedica Osteonics Corp. | a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. |
| 2025-07-11 | Onkos Surgical, Inc. | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| 2025-07-11 | Onkos Surgical, Inc. | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| 2025-07-11 | Onkos Surgical, Inc. | Unidentified substance of unknown impact was identified on devices during a retrospective evaluation. |
| 2024-08-05 | Howmedica Osteonics Corp. | A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. |
| 2024-07-02 | Zimmer, Inc. | Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF. |
| 2024-05-17 | Biomet, Inc. | 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention |
| 2023-12-22 | Onkos Surgical, Inc. | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as st |
| 2023-12-22 | Onkos Surgical, Inc. | Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as st |
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