Anspach Effort Recalls G1 Dissection Tools Due to Labeling Error
The Anspach Effort, Inc. is recalling 88 G1 Dissection Tools because product codes were inadvertently left off Hold 1503.
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, but the source text identifies the issue as a documentation error (missing product codes) without reporting any injuries or illnesses, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
The Anspach Effort, Inc. is recalling 88 units of the G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M. These medical devices are used for cutting and shaping bone, including the spine and cranium.
The firm discovered on March 4, 2016, that several product codes were inadvertently left off of Hold 1503. The affected units are identified by Material M-3DC-2-G1 and Batch J313108568 & J316017637.
The products were distributed to Arizona, the District of Columbia, California, Maryland, Michigan, Oregon, and Switzerland. Consumers and healthcare providers should stop using these specific units and contact the manufacturer for instructions.
The recalled product
- Product
- G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 88
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 (1)
- Material M-3DC-2-G1 Batch J313108568 & J316017637
Distribution
Part of a larger recall action
This product is one of 4 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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