The Recall Desk
ModerateFDA (Devices)·Z-1968-2017·Announced 2017-05-10

Anspach Effort Recalls 16.5cm Micro Revision Attach Due to Missing Service Interval

The Anspach Effort, Inc. is recalling 17 units of the 16.5cm Micro Revision Attach because the supplied directions for use did not include 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 specific defect is 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 17 units of the 16.5cm Micro Revision Attach, Black Max. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval. The product is identified by Part No. B-MRA-M and DFU 18-0062.

The affected units were distributed worldwide, including in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. All serial numbers for the shipped units are available to customers.

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

The recalled product

Product
16.5CM MICRO REVISION ATTACH, BLACK MAX
Affected units
17

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-M.

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 →