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 five AL-III-DISS Adapters because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 9,829 pneumatic attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 224 Bearing Sleeves because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 45 degree Contra Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 158 eMax2 Motor Assemblies because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 45 units of the 11CM Angle Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 128 Compact Speed Reducer units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 293 eMax2 Hybrid Hand Controls because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 821 Electronic Foot Controls because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 25 units of the 22CM Micro Revision Attach because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling Autolube-III pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 17 AL-III pneumatic hose units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling Adult Craniotome Pneumatic Systems because the supplied Directions for Use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 2,339 units of the 5.0cm Heavy Duty Short Attachment because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 41 units of the 19CM Attachment, Black Max because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 91 units of the 14cm QD Angle Attachment because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 80 units of the 8.2cm Black Max pneumatic attachment because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 17 units of the 16.5cm Micro Revision Attach because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 31 Large Craniotome, Black Max units because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 216 units of the 11.25cm Black Max attachment because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 618 Minimal Access Attachment pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 121 Bearing Sleeves because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 22 Sagittal Saw pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 177 units of the 16cm Minimally Invasive Attachment because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 19 AL-III pneumatic systems because the supplied directions for use did not contain a recommended service interval.