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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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
Similar recalls
- ModerateAnspach Effort Recalls 5.0cm Heavy Duty Short Attachment for Missing Service Interval
FDA (Devices) · 2017-05-10
- ModerateAnspach Effort Recalls Heavy Duty Long Heavy Short Attachment
FDA (Devices) · 2017-05-10
- HighAnspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk
FDA (Devices) · 2014-01-15
- LowAnspach Effort 6.8cm Controlled Depth Attachment Recalled for Missing Service Interval
FDA (Devices) · 2017-05-10
- ModerateAnspach Effort Recalls 14cm QD Angle Attachments Due to Missing Service Interval
FDA (Devices) · 2017-05-10
- ModerateAnspach Effort 7.2cm Adjustable Drill Guide Recalled for Missing Service Interval
FDA (Devices) · 2017-05-10