The Recall Desk
ModerateFDA (Devices)·Z-1964-2017·Announced 2017-05-10

Anspach Effort Recalls Adjustable Drill Guide for Missing Service Interval

The Anspach Effort, Inc. is recalling six units of the Adjustable Drill Guide, Black Max because the supplied directions for use did not contain a recommended service interval.

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, and the hazard involves a documentation issue (missing service interval) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The Anspach Effort, Inc. is recalling six units of the Adjustable Drill Guide, Black Max. The recall was initiated because the supplied directions for use (DFU) did not contain a recommended service interval.

The affected product is identified by DFU 18-0062 and Part No. B-GREY-ADG. All serial numbers were shipped to customers. The product was distributed worldwide, including US nationwide in the states of HI and DC, Puerto Rico, Guam, and Japan.

Consumers who possess this product should stop using it and contact The Anspach Effort, Inc. for further instructions.

The recalled product

Product
ADJUSTABLE DRILL GUIDE, BLACK MAX
Affected units
6

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 (3)

  • All serial numbers shipped to customers
  • DFU 18-0062
  • Part No. B-GREY-ADG.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 103 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 103 products in this recall →