The Recall Desk
HighFDA (Devices)·Z-2229-2014·Announced 2014-08-20

Zimmer Recalls Nonsterile VER2 Handle Due to Assembly Failure

Zimmer, Inc. is recalling 412 units of the VER2 Handle, Pin Rework, RT 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 is classified as FDA Class II. The hazard involves a mechanical failure (fracture of the leaf spring) that could lead to injury during use, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is recalling 412 units of the VER2 Handle, Pin Rework, RT Nonsterile (Item Number 82-0167-613-32, Lot Number 97010151). The recall was initiated after the firm received complaints that the handle failed to remain assembled to the rasp during use. The failure modes included fracture of the leaf spring.

The affected products were distributed nationwide in the United States, including in Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, and Virginia. The products were also distributed in Australia, France, Germany, Italy, Switzerland, and Canada.

Consumers and healthcare facilities should stop using the affected handles and contact Zimmer, Inc. for further instructions or a replacement.

The recalled product

Product
VER2 HANDLE, PIN REWORK, RT Nonsterile
Manufacturer
Zimmer, Inc.
Category
Medical Device — Surgical Instrument
Hazard
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 (1)

  • Item Number 82-0167-613-32 Lot Number 97010151

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 →

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Same hazard · mechanical failure

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