The Recall Desk
ModerateFDA (Devices)·Z-2839-2016·Announced 2016-09-28

Anspach Effort G1 Dissection Tool Recall for Missing Product Codes

The Anspach Effort, Inc. is recalling 63 G1 Dissection Tools because several product codes were inadvertently left off of 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, but the source text explicitly states the issue is a documentation error (missing product codes) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling 63 units of the G1 Dissection Tool - 3mm FLUTED BALL. This medical device is used for cutting and shaping bone, including the spine and cranium. The recall was initiated after 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-3SB-2-G1 Batch J316017640. The products were distributed to locations in Arizona, the District of Columbia, California, Maryland, Michigan, Oregon, and Switzerland.

The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself. No injuries or illnesses have been reported in the provided text.

The recalled product

Product
G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
Affected units
63

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-3SB-2-G1 Batch J316017640

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 →