The Recall Desk
SevereFDA (Devices)·Z-2225-2014·Announced 2014-08-20

Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure

Zimmer, Inc. is recalling 412 nonsterile VER2 D8L Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural defects in medical devices that could lead to significant injury.

Plain-English summary

Zimmer, Inc. is recalling 412 units of the VER2 D8L Offset Rasp Handle, RT Nonsterile. The recall involves Item Number 82016761302 and Lot Numbers 97009564, 97009565, and 97009570.

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 product was distributed nationwide in the United States and in Australia, France, Germany, Italy, Switzerland, and Canada.

This recall is classified as Class II by the FDA. Users should stop using the affected handles and contact Zimmer, Inc. for further instructions.

The recalled product

Product
VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic 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 (3)

  • Item Number 82016761302 Lot Number 97009564
  • 97009565
  • 97009570

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 →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · structural failure

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