The Recall Desk
ModerateFDA (Devices)·Z-2840-2016·Announced 2016-09-28

Anspach Effort Recalls G1 Dissection Tools Due to Labeling Error

The Anspach Effort, Inc. is recalling 69 G1 Dissection Tools because product codes were inadvertently left off Hold 1503.

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 due to a labeling error (missing product codes) with no reported injuries or illnesses, fitting the criteria for moderate severity involving minor labeling issues.

Plain-English summary

The Anspach Effort, Inc. is recalling 69 units of the G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M. These tools are used for cutting and shaping bone, including the spine and cranium. The affected units are identified by Material M-6DC-2-G1 with Batch J313108573 and J 316017642.

The firm discovered on March 4, 2016, that several product codes were inadvertently left off of Hold 1503. This is a Class II recall, indicating that use of or exposure to the product might cause temporary or medically reversible adverse health consequences.

The products were distributed in Arizona, the District of Columbia, California, Maryland, Michigan, Oregon, and Switzerland. Consumers and healthcare providers should stop using these specific tools and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
Affected units
69

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-6DC-2-G1 Batch J313108573 and J 316017642

Distribution

Distributed in 6 states:

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.

See all 4 products in this recall →