FDA (Devices) recall action 96782
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
Potential for breach of Tyvek seals.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Onkos Surgical is recalling Segmental Stem components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise sterility.
Onkos Surgical is recalling Segmental Stem, Canal Filling, Bowed 152MM components of the ELEOS Limb Salvage System due to potential breach of Tyvek seals. The defect could compromise the sterility of the device.
Onkos Surgical is recalling Male-Female Midsection components used in the ELEOS Segmental Limb Salvage System due to potential for breach of Tyvek seals. The recall affects 99 units distributed across 18 states.
Onkos Surgical is recalling segmental stems used in the ELEOS LIMB SALVAGE SYSTEM due to potential breach of Tyvek seals. The breach could compromise the sterility of the medical device.
Onkos Surgical is recalling segmental stem components of the ELEOS Limb Salvage System due to potential for breach of Tyvek seals. The affected components were distributed across multiple states.
Onkos Surgical is recalling Ethos Collar Stem components used in limb salvage systems due to potential breach of Tyvek seals. The recall affects 233 units distributed across multiple U.S. states.