Anspach Effort 6.5cm Adult Cranial Thin Foot Plate Recall
The Anspach Effort, Inc. is recalling 130 units of 6.5cm Adult Cranial Thin Foot Plates because the supplied directions for use did not contain a recommended service interval.
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. The hazard is a documentation issue (missing service interval in the Directions for Use) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 130 units of the 6.5cm Adult Cranial Thin Foot Plate, Part No. CRANI-A-01. This medical device is used in a pneumatic system. The recall affects all serial numbers shipped to customers prior to September 27, 2016, under DFU 18-0048.
The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval. The product was distributed worldwide, including the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan.
Consumers and healthcare providers should stop using the affected devices and contact The Anspach Effort, Inc. for further instructions on how to proceed.
The recalled product
- Product
- 6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 130
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)
- All serial numbers shipped to customers prior to 09/27/2016
- DFU 18-0048
- Part No. CRANI-A-01.
Distribution
Part of a larger recall action
This product is one of 103 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.
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