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 90 degree Contra Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling foot control irrigation systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 130 units of 6.5cm Adult Cranial Thin Foot Plates because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 119 Otologic Curved Micro pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 49 units of the 5.9CM Attachment, Black Max, because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 112 Bearing Sleeves because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 11 units of the 9.4cm Micro Revision Attach, Black Max because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 455 units of 11cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 17 units of the 14CM Angle Attachment, Black Max because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 238 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 32 electric handpiece controls because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 11.0cm Long Attachments for pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling six units of the Adjustable Drill Guide, Black Max because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling eight Green Rotating Craniotomes because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 65 Reciprocating MICRO SAW units 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 10 units of the 90 Degree Right Angle Attach, Black Max, because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling Large Craniotome pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 714 Compact Speed Reducers because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 7.5cm Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 375 units of 7.5cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 247 pneumatic system attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 239 System Console units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 203 units of the 10.5cm QD Angle Attachment because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling three IMRI Motor pneumatic systems because the supplied directions for use did not contain a recommended service interval.