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LINX

Torax Medical, Inc. · Model LS-[14] · UDI-DI 00855106005035

LEI Prescription

510(k) clearances

2,244

Adverse events (2 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2018-04-20	Torax Medical, Inc.	Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
2018-04-20	Torax Medical, Inc.	Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
2018-04-20	Torax Medical, Inc.	Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
2018-04-20	Torax Medical, Inc.	Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
2018-04-20	Torax Medical, Inc.	Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

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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.