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Trinity Acetabular Hip System with HXLPE Liners

CORIN LTD · Model 321.03.636 · UDI-DI 05055196971509

MEHLZO Prescription
1
510(k) clearances
10,210
Adverse events (13 deaths)
197
Recalls
190
Facilities

Description

Trinity Liner (HXLPE) Ø36mm Neutral Offset Taper Size 3

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 for elevated levels o
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 devices.
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 devices.
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 devices.
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 devices.
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 devices.
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 devices.
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 devices.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.