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 four Custom Medium Attachments because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling two eMax 2 Plus Hand Controls because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling two Custom Device Speed Reducer units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Custom MDA Tubes because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Nose Cone Covers because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling custom shoulder implants because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 21 eMax2 Lower Profile Foot Pedals because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 20 Anspach Custom MCA5-1SD devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling nine Custom eMax 2 Plus Motors because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Devices, specifically arthroscopic suture anchor threaders, because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Device Autolube III units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Knotless Suture Anchor Deployment Tools because the units and records were not consistent with Quality System requirements.
The Anspach Effort, Inc. is recalling 10 units of 8 mm Coarse Threaded Headless Bone Screws because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Autolube Food Guard devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling six eMax 2 Modified Hand Control units because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 68 arthroscopic suture anchor assemblies because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 100 units of Arthroscopic Knotless Suture Anchors because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Circular ePLUS-FP devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 130 units of 4mm Fluted Balls for MRI because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
The Anspach Effort, Inc. is recalling 10 units of the 2.37mm Spiral Drill because they were not manufactured consistently with Quality System requirements.