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Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

FDA product code MEH · Class 2 · Orthopedic

0
Registered devices
10,235
Adverse events
197
Recalls
160
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-07-30Howmedica Osteonics Corp.Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential f
2025-09-11Theken Companies LLCDownstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
2022-08-11Exactech, Inc.Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
2021-07-28Corin LtdThe packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devi
2021-07-28Corin LtdThe packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devi
2021-07-28Corin LtdThe packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devi
2021-07-28Corin LtdThe packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devi
2021-07-28Corin LtdThe packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devi
2021-07-28Corin LtdThe packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devi
2021-07-28Corin LtdThe packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devi

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.