The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2223-2014·Announced 2014-08-20

Zimmer Recalls Nonsterile Orthopedic Rasps Due to Handle Failure

Zimmer, Inc. is recalling 412 units of nonsterile orthopedic rasps because the handle may fail to remain assembled during use.

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 3/5 (High).

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, and the source describes a functional failure of a medical device during use without reporting 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 Vl DBL OFFST WI LRG STPL, RT Nonsterile orthopedic rasp. The recall is being conducted because the firm received complaints that the handle failed to remain assembled to the rasp during use. The failure modes included the fracture of the leaf spring.

The affected product is identified by Item Number 82016757942 and Lot Numbers 97009220, 97009255, 97009256, and 97009585. The products were distributed nationwide in the United States, including specific states such as AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA. The products were also distributed in Australia, France, Germany, Italy, Switzerland, and Canada.

Healthcare providers and facilities should stop using the affected rasps and contact Zimmer, Inc. for further instructions on the recall.

The recalled product

Product
Vl DBL OFFST WI LRG STPL, 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 (4)

  • Item Number 82016757942 Lot Number 97009220
  • 97009255
  • 97009256
  • 97009585

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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