FDA (Devices) recall action 74757
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.
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.
Integra LifeSciences is recalling 111 units of External Fixation System Slotted Posts because they broke during use at the surgical site.
Integra LifeSciences Corp. is recalling Universal Wire Fixation Bolts because the Slotted Post broke during use at the surgical site.