Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices because they were not manufactured consistently with Quality System requirements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text cites a manufacturing quality system defect without reporting specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The recall is due to the units not being manufactured consistently with Quality System requirements.
The affected product is the Anspach Custom Devices, specifically the Adjustable 25 Cm Mia Attachment, Custom (Part Number: SP-3101-00; Serial Number: 200045). This device is intended to be used with Anspach Systems and is available by prescription only.
The units were distributed worldwide, including in the United States (AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. Consumers should contact the recalling firm for further instructions.
The recalled product
- Product
- ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number: SP-3101-00
- Serial Number: 200045
Distribution
Part of a larger recall action
This product is one of 45 recalled by The Anspach Effort, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 45 products in this recall →Related recalls
Same manufacturer · The Anspach Effort, Inc.
See all →- HighAdult Craniotome Bearings May Detach During Surgical Use
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Separate During Surgery
FDA (Devices) · 2023-01-18
- HighLarge Craniotome Attachment Ball Bearings Risk Loosening During Surgery
FDA (Devices) · 2023-01-18
- HighAnspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Detach During Surgery
FDA (Devices) · 2023-01-18
Same hazard · quality system non compliance
See all →- HighDiagnostic test products recalled by Universal Meditech for missing FDA clearance
FDA (Devices) · 2023-11-01
- HighUnauthorized Distribution of Multiple Diagnostic Tests Recalled by Universal Meditech
FDA (Devices) · 2023-11-01
- ModeratePregnancy test strips recalled for lack of FDA authorization and quality documentation
FDA (Devices) · 2023-11-01
- ModerateValorem Surgical Recalls Pallas M Tapper Spinal Fixation Devices
FDA (Devices) · 2017-08-16
- ModerateValorem Surgical Recalls Pallas M/MAXIMIS 40mm Rods for Quality Issues
FDA (Devices) · 2017-08-16