FDA (Devices) recall action 76059
The FDA (Devices) publishes a recall like this one as 103 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 103 pages.
Supplied Directions for Use (DFU) did not contain a recommended service interval.
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.
The Anspach Effort, Inc. is recalling three Pediatric Craniotomes because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 182 Bearing Sleeve, 10CM Curved units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 13 units of the 10.5cm Angle Attachment, Black Max, because the supplied directions for use did not include a recommended service interval.