The Recall Desk
ModerateFDA (Devices)·Z-1958-2017·Announced 2017-05-10

Anspach Effort 7.2cm Adjustable Drill Guide Recalled for Missing Service Interval

The Anspach Effort, Inc. is recalling 198 units of the 7.2cm Adjustable Drill Guide 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: This is an FDA Class II recall involving a documentation issue (missing service interval) 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 198 units of the 7.2cm Adjustable Drill Guide, Part No. ADG. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.

The affected products were distributed worldwide, including US Nationwide in the states of HI, DC, Puerto Rico, Guam, and Japan. All serial numbers were shipped to customers, and the specific DFU reference is 18-0048.

Consumers should stop using the product and contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.

The recalled product

Product
7.2cm Adjustable Drill Guide Product Usage: Electric system
Affected units
198

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 18-0048
  • Part No. 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 →