The Recall Desk
LowFDA (Devices)·Z-1970-2017·Announced 2017-05-10

Anspach Effort Recalls Black Max Contra Angle Attachments for Missing Service Interval

The Anspach Effort, Inc. is recalling two Black Max contra angle attachments because the supplied directions for use did not contain a recommended service interval.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is due to a documentation issue (missing service interval in the directions for use) with no reported injuries or illnesses, which aligns with the 'Low' severity criteria for documentation issues.

Plain-English summary

The Anspach Effort, Inc. is recalling two units of the Black Max contra angle attachment. The recall was initiated because the supplied directions for use (DFU) did not contain a recommended service interval.

The affected units are identified by DFU 18-0062 and Part No. B-ORANGE-45. All serial numbers were shipped to customers. The products were distributed worldwide, including the US nationwide (specifically HI and DC), Puerto Rico, Guam, and Japan.

Consumers and healthcare providers should stop using the affected attachments and contact The Anspach Effort, Inc. for further instructions.

The recalled product

Product
CONTRA ANGLE ATTACHMENT, BLACK MAX
Affected units
2

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-ORANGE-45.

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 →