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 50 units of the SMALL ATTACHMENT, JACOBS CHUCK because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 58 Bearing Sleeve units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 17 Autolube-III pneumatic systems because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 16CM Min Invasive Attach, Black Max units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 16 Autolube-III pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 415 units of 8cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 13.5CM Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling five Black Max Keyless Drivers because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 239 Autolube-III pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 16 Oscillating MICRO-SAW pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 62 Sagittal MICRO-SAW units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 49 Rotating Adult Craniotomes because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 51 units of the Autolube-III with Irrigation pneumatic system because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 5,757 units of the 5.0cm Short Attachment because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 16 Small Attachment, J-Latch units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 121 Keyless Driver pneumatic systems because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 6.8cm Controlled Depth Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 14cm QD Angle Attachments because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 22 XMAX Motor High Strength Hoses because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 297 pneumatic tapered attachments because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 22 SC2100 foot controls because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 462 System Console units because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling eight Rotating Large Craniotomes because the supplied directions for use did not include a recommended service interval.
The Anspach Effort, Inc. is recalling 568 Bearing Sleeves because the supplied directions for use did not contain a recommended service interval.
The Anspach Effort, Inc. is recalling 14 IMRI Short Attachment units because the supplied directions for use did not include a recommended service interval.