FDA (Devices) recall action 96911
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.
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
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.
Limacorporate is recalling PRIMA 2MM Eccentrical Adaptor With Screw sterile devices because the black laser marking used to identify position may be missing.
Limacorporate S.p.A is recalling PRIMA 4MM Eccentrical Adaptor with Screw devices because the black laser marking used to identify positioning may be missing. The defect could affect proper device placement during use.