Agency classClass IIOur severity:High FDA (Devices)·Z-2222-2014·Announced 2014-08-20

Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp 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. While no specific injuries are reported in the source text, the mechanical failure of a surgical instrument during use presents a risk of harm, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is recalling 412 units of the Double Offset Rasp Handle, Right Hand Nonsterile. The recall involves Item Number 82016757932 and specific lot numbers: 97008288, 97900067, 97900085, 97900107, and 97900157.

The firm received complaints that the handle failed to remain assembled to the rasp during use. This failure was attributed to various modes, including the fracture of the leaf spring. The affected products were distributed nationwide in the United States and in several international countries, including Australia, France, Germany, Italy, Switzerland, and Canada.

Healthcare providers and consumers should stop using the affected handles and contact Zimmer, Inc. for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Double Offset Rasp Handle, Right Hand Nonsterile
Manufacturer: Zimmer, Inc.
Category: Medical Device — Surgical Instrument
Hazard: mechanical-failure
injury-risk
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 (5)

Item Number 82016757932 Lot Number 97008288
97900067
97900085
97900107
97900157

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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