FDA (Devices) recall action 88684
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.
Engraving on implants may not match what is listed on the pouch labels.
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.
Medtronic Sofamor Danek is recalling the Endoskeleton TAS Interbody System because the engraving on the implants may not match the information on the pouch labels.
Medtronic is recalling 9 Endoskeleton TCS Interbody System surgical implants because engraving on the devices may not match the labels on the pouches. The mismatch could result in wrong devices being implanted.