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 439 eMax2 Plus consoles because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling five B-Sagittal Assembly pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 148 Standard Craniotomes because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 679 Pediatric Craniotomes because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 16 units of the 26.65cm Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 320 SC2100 Foot Controls because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 554 XMAX Pneumatic Drill Systems because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 10 IMRI CRANI-A pneumatic attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling three IMRI Air Control pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 207 Electronic Foot Controls because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 98 Minimal Access Straight Drivers because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 206 units of the 20.2cm Heavy Duty Long Heavy Short Attachment because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling eight Chuck Driver Systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 209 Electronic Foot Controls with Direction Switches because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 3,434 eMax2 PLUS electric systems because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 8.0CM Heavy Duty Medium Pneumatic Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling five IMRI Short HD Pneumatic Attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 8.0cm Medium Pneumatic System Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 297 pneumatic system attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling two Black Max contra angle attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 22 Minimal Access Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 10.5cm Long Attachments for pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 8CM Angle Attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 25 BLACKMAX-NEURO LOW PRESSURE pneumatic systems because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 198 units of the 7.2cm Adjustable Drill Guide because the supplied directions for use did not contain a recommended service interval.