FDA (Devices) recall action 96349
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Potential for the gold unlock button to separate from the inserter.
The agency’s own wording, quoted from the enforcement report.
Stryker Spine is recalling the Monterey AL Implant Inserter (22mm, Catalog 48019140) due to potential separation of the gold unlock button from the device. The recall affects 41 units in the United States and 3 internationally.
Stryker Spine is recalling the Monterey AL Implant Inserter because the gold unlock button may separate from the device, which could affect functionality during surgical procedures.
Stryker Spine has recalled 56 units of the Monterey AL Implant Inserter due to potential separation of the gold unlock button. This could impair the device's function during surgical implant placement.
Stryker Spine is recalling Monterey AL Implant Inserters due to a potential defect where the gold unlock button may separate from the device, compromising its function during spinal surgery.