The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2032-2017·Announced 2017-05-10

Anspach Effort Recalls Heavy Duty Long Heavy Short Attachment

The Anspach Effort, Inc. is recalling 206 units of the 20.2cm Heavy Duty Long Heavy Short Attachment because the supplied directions for use did not contain a recommended service interval.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 is a missing service interval in the directions for use, which is a documentation issue that could lead to improper maintenance but does not involve a direct, immediate physical hazard like a defect or contamination.

Plain-English summary

The Anspach Effort, Inc. is recalling 206 units of the 20.2cm Heavy Duty Long Heavy Short Attachment. The recall was initiated because the supplied directions for use (DFU) did not contain a recommended service interval.

The affected products are identified by Part No. XL-HD and DFU 18-0048. The recall includes all serial numbers shipped to customers prior to 09/27/2016. The products were distributed worldwide, including US Nationwide in the states of HI, DC, Puerto Rico, Guam, and Japan.

Consumers should stop using the product and contact The Anspach Effort, Inc. for further instructions.

The recalled product

Product
20.2cm Heavy Duty Long Heavy Short Attachment
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
206

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 prior to 09/27/2016
  • DFU 18-0048
  • Part No. XL-HD.

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 →

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