Anspach Effort B-Sagittal Assembly Pneumatic System Recall
The Anspach Effort, Inc. is recalling five B-Sagittal Assembly pneumatic systems 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, but the source text explicitly identifies the issue as a missing service interval in the documentation without reporting any injuries, illnesses, or specific safety hazards. This aligns with the rubric for moderate severity involving documentation issues or minor labeling errors.
Plain-English summary
The Anspach Effort, Inc. is recalling five B-Sagittal Assembly pneumatic systems. The recall was initiated because the supplied directions for use (DFU) did not contain a recommended service interval.
The affected units are identified by Part No. B-SAGITTAL and DFU 18-0062. The recall includes all serial numbers shipped to customers prior to 09/27/2016. Distribution was worldwide, including the United States (specifically HI and DC), Puerto Rico, Guam, and Japan.
Consumers should contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 5
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 18-0062
- Part No. B-SAGITTAL.
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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