Home › Device types › JDI
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
FDA product code JDI · Class 2 · Orthopedic
22,782
Registered devices
70,453
Adverse events
255
Recalls
564
510(k) clearances
Devices with this code
PINNACLE GRIPTION — DEPUY (IRELAND)R3 — Smith & Nephew, Inc.P.C.A. — Howmedica Osteonics Corp.APR® — Zimmer, Inc.Trident — Howmedica Osteonics Corp.Trident X3 Insert — Howmedica Osteonics Corp.Perfecta — Microport Orthopedics Inc.MCS — Exactech, Inc.G7 PROVISIONAL 10 DEGREE FACE CHANGING LINER — Biomet Orthopedics, LLCNA — Exactech, Inc.UniSyn Hip System — Shalby Advanced Technologies, Inc.ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, LLCRINGLOC HIP SYSTEM — Biomet Orthopedics, LLCOrthopedic Salvage System (OSS) — Biomet Orthopedics, LLCArcos® STS™ Modular Revision System — Biomet Orthopedics, LLCNA — Zimmer, Inc.NA — Smith & Nephew, Inc.Metafix Hip Stem — CORIN LTDB-P TOTAL HIP SYSTEM — ENDOTEC, INC.RingLoc® Hip System — Biomet Orthopedics, LLCG7® — Biomet Orthopedics, LLCRINGLOC HIP SYSTEM — Biomet Orthopedics, LLCTrabecular Metal® Longevity® — Zimmer, Inc.ZMR® — Zimmer, 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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