FDA (Devices) recall action 64247
The FDA (Devices) publishes a recall like this one as 45 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 45 pages.
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.
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 eMax Hand Control units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 20 units of 2mm Coarse Diamond Ball attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 113 MRI fluted routers because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 45 Anspach Custom XMax Pneumatic Motors because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling three Custom QD11 Attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling six Modified QD11 Attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 13 mm Drills with Depth Stops because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 8 mm Coarse Headless Screws because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling three XMax Motor units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Modified Arthroscopic Knotless Suture Anchor Deployment Tools because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Modified MDA Tubes with MA-D20 Attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 16 custom pneumatic motor devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Device SC2102 units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 40 units of 3mm Coarse Diamond Ball attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 50 units of 5mm Coarse Diamond Ball devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling eMax2 Plus Hand Controls because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling two custom extension bearing sleeves because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling two custom Sagittal microSaw Attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling eMax2 Console units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling specific custom medical devices because they were not manufactured consistently with Quality System requirements.