FDA (Devices) recall action 91183
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.
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
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.
Corin Ltd is recalling BIOLOX DELTA ceramic hip replacement heads because some units are labeled with incorrect sizes. The recall affects 12 units distributed in seven U.S. states.
Corin Ltd is recalling BIOLOX Delta Ceramic Hip Implant Heads nationwide due to size labeling errors. The 36XL size is labeled as 32XL and vice versa, which could result in implantation of an incorrectly sized component.