FDA (Devices) recall action 76986
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.
Some eyelets broke from SwiveLock Anchor on insertion.
The agency’s own wording, quoted from the enforcement report.
Arthrex is recalling specific batches of Bio Composite SwiveLock anchors because some eyelets broke during insertion.
Arthrex is recalling specific SpeedBridge Implant Systems because some eyelets broke during insertion. The recall covers multiple batches distributed in the US and internationally.
Arthrex, Inc. is recalling specific Bio-SwiveLock SP Vented anchors because some eyelets broke during insertion.
Arthrex, Inc. is recalling the Anthrex SpeedBridge Implant System because some eyelets broke from the SwiveLock Anchor during insertion.
Arthrex, Inc. is recalling specific Anthrex PEEK SwiveLock SP Vented anchors because some eyelets broke during insertion. The recall covers units distributed in the US and several international locations.
Arthrex, Inc. is recalling specific Anthrex PEEK SwiveLock SP Vented anchors because some eyelets broke during insertion.