Anspach Custom Devices Recalled for Quality System Manufacturing Inconsistencies
The Anspach Effort, Inc. is recalling specific custom medical 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, but the source text does not report any illnesses, injuries, or specific safety hazards, 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 specific units involved in this recall are identified by Part Number 98-0008 and Serial Numbers 20033001 and 20033002. These devices are intended to be used with Anspach Systems and are marked as Rx Only.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The source text does not specify the exact nature of the manufacturing inconsistencies or any specific safety hazards associated with the defect.
The affected units were distributed worldwide, including to the United States (specifically AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, and TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. Consumers and healthcare providers should check their inventory for the specific part and serial numbers listed above. The source text does not provide specific instructions for consumers on how to return the devices or what to do if they are currently using them.
The recalled product
- Product
- ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 2
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 (3)
- Part Number: 98-0008
- Serial Numbers: 20033001
- 20033002.
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