FDA (Devices) recall action 98608
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.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
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.
Heraeus Medical is recalling PALAMIX uno dental material because the mixing rod may come loose during mixing in units older than 1.5 years. The shelf life has been reduced from 3 years to 1.5 years.
Heraeus Medical is recalling PALAMIX duo dental mixing units (Material Number 66057897) because the mixing rod may come loose from its lock during use in units older than 1.5 years. The shelf life is being reduced from 3 years to 1.5 years.