The Recall Desk
ModerateFDA (Devices)·Z-1967-2017·Announced 2017-05-10

Anspach Effort Recalls 22CM Micro Revision Attach Due to Missing Service Interval

The Anspach Effort, Inc. is recalling 25 units of the 22CM Micro Revision Attach 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, but the source text identifies the issue as a missing service interval in the documentation without reporting any injuries, illnesses, or specific safety hazards, fitting the criteria for a moderate severity labeling/documentation issue.

Plain-English summary

The Anspach Effort, Inc. is recalling 25 units of the 22CM Micro Revision Attach, Black Max (Part No. B-MRA-L). The recall is being conducted because the supplied Directions for Use (DFU) did not contain a recommended service interval.

The affected products were distributed worldwide, including in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. The recall number is Z-1967-2017.

Consumers who possess this product should stop using it and contact The Anspach Effort, Inc. for instructions on how to proceed.

The recalled product

Product
22CM MICRO REVISION ATTACH, BLACK MAX
Affected units
25

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-MRA-L.

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 →