FDA (Devices) recall action 80131
The FDA (Devices) publishes a recall like this one as 16 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 16 pages.
The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
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.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and lead to premature breakage.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.
Stryker GmbH is recalling nine femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce component strength and lead to premature breakage.
Stryker GmbH is recalling seven femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.
Stryker GmbH is recalling specific ankle arthrodesis nails because non-conforming cannulation may reduce strength and cause premature breakage.
Stryker GmbH is recalling two femoral nails that may have non-conforming cannulation, potentially leading to reduced strength and premature breakage.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.
Stryker GmbH is recalling specific femoral nails due to potential manufacturing defects that could cause the device to break prematurely.
Stryker GmbH is recalling specific Tibial Nails because non-conforming cannulation may reduce strength and cause premature breakage.
Stryker GmbH is recalling specific femoral nails due to potential manufacturing defects that could cause the device to break prematurely.
Stryker GmbH is recalling specific ankle arthrodesis nails because non-conforming cannulation may reduce strength and cause premature breakage.
Stryker GmbH is recalling 17 femoral nails because non-conforming cannulation may reduce component strength and cause premature breakage.
Stryker GmbH is recalling specific femoral nails because non-conforming cannulation may reduce strength and cause premature breakage.