The Recall Desk
ModerateFDA (Devices)·Z-2837-2016·Announced 2016-09-28

Anspach Effort Recalls G1 Dissection Tools Due to Release Error

The Anspach Effort, Inc. is recalling 177 G1 Dissection Tools because they were inadvertently released from hold status and distributed.

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 indicates the issue was an administrative release error without any reported injuries or specific safety hazards, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling 177 units of the G1 Dissection Tool - 7mm FBALL L. This medical device is used for cutting and shaping bone, including the spine and cranium. The recall is being conducted because the product code L-7B-G1 was inadvertently released from hold status, resulting in the distribution of the affected units.

The affected products were distributed to locations in Arizona, the District of Columbia, California, Maryland, Michigan, Oregon, and Switzerland. The specific batch code for the recalled items is K043113667.

The source text does not specify any reported injuries, illnesses, or specific hazards associated with the use of these devices. Consumers and healthcare providers should stop using the affected G1 Dissection Tools and contact The Anspach Effort, Inc. for further instructions.

The recalled product

Product
G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
177

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 L-7B-G1 Batch K043113667

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 →

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