The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2219-2014·Announced 2014-08-20

Zimmer Recalls Nonsterile Orthopedic Rasps Due to Handle Assembly Failure

Zimmer, Inc. is recalling 412 units of nonsterile VI DBL OFFST W/ LRG STPL, LT 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 involves a mechanical failure of a medical device during use, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Zimmer, Inc. is recalling 412 units of the VI DBL OFFST W/ LRG STPL, LT Nonsterile orthopedic rasp. The recall is due to complaints that the handle failed to remain assembled to the rasp during use. The failure modes include fracture of the leaf spring.

The affected products are identified by Item Number 82016757841 and Lot Numbers 97009219 and 97009254. These units 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.

The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected rasps and contact Zimmer, Inc. for further instructions.

The recalled product

Product
VI DBL OFFST W/ LRG STPL, LT 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 (2)

  • Item Number 82016757841 Lot Number 97009219
  • 97009254

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.

See all →

Same hazard · mechanical failure

See all →

Similar recalls