The Recall Desk
HighFDA (Devices)·Z-2224-2014·Announced 2014-08-20

Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure

Zimmer, Inc. is recalling 412 units of VER2 DBL OFFSET RASP HANDLE, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical failure (fracture of leaf spring) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Zimmer, Inc. is recalling 412 units of the VER2 DBL OFFSET RASP HANDLE, LT Nonsterile. The recall involves Item Number 82016761201 and Lot Numbers 97009494, 97009561, and 97009569. The product was distributed nationwide in the United States and in Australia, France, Germany, Italy, Switzerland, and Canada.

The firm received complaints that the handle failed to remain assembled to the rasp during use. The source text attributes this to various failure modes, including the fracture of the leaf spring.

Consumers and healthcare providers should stop using the affected products and contact Zimmer, Inc. for further instructions.

The recalled product

Product
VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
Manufacturer
Zimmer, Inc.
Affected units
412

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)

  • Item Number 82016761201 Lot Number 97009494
  • 97009561
  • 97009569

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Part of a larger recall action

This product is one of 16 recalled by Zimmer, 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 16 products in this recall →