Anspach 13 mm Drill with Depth Stop Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 13 mm Drills with Depth Stops 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 does not report any illnesses, injuries, or deaths, indicating a moderate risk level associated with manufacturing non-compliance.
Plain-English summary
The Anspach Effort, Inc. is recalling its Anspach Custom Devices, specifically the 13 mm Drill with Depth Stop for Short Heavy Duty Attachment. The recall was initiated because the units were not manufactured consistently with Quality System requirements.
The affected units are identified by Part Number SP-3012-00 and Serial Number 200294. A total of 5 units are involved in this recall. The devices were distributed worldwide, including to specific states in the United States and internationally to Canada, Japan, Hungary, Korea, and Sweden.
Consumers should stop using the affected devices and contact The Anspach Effort, Inc. for further instructions regarding the recall.
The recalled product
- Product
- ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- 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 (2)
- Part Number: SP-3012-00
- Serial Number: 200294
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.
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