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b-ONE™ Primary Acetabular System

B-ONE ORTHO, CORP. · Model 881201361H · UDI-DI 00843575102485

MEH HWC LZO Prescription

510(k) clearances

10,185

Adverse events (13 deaths)

196

Recalls

189

Facilities

Description

Acetabular Liner, Hooded, 10 degree; Vitamin E UHMWPE; 36mm Inner Diameter, Size H

Recalls

Date	Firm	Reason
2025-09-11	Theken Companies LLC	Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
2022-08-11	Exactech, Inc.	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
2021-07-28	Corin Ltd	The 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.
2021-07-28	Corin Ltd	The 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.
2021-07-28	Corin Ltd	The 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.
2021-07-28	Corin Ltd	The 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.
2021-07-28	Corin Ltd	The 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.
2021-07-28	Corin Ltd	The 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.
2021-07-28	Corin Ltd	The 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.
2021-07-28	Corin Ltd	The 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.