Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0538-2013·Announced 2012-12-26

Zimmer Recalls Coonrad/Morrey Elbow Replacement Kits Due to Pin Error

Zimmer is recalling specific lots of Coonrad/Morrey elbow replacement kits because they may contain an incorrect small inner pin instead of the required regular pin.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a component substitution (small pin instead of regular pin) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer, Inc. is initiating a lot-specific recall of the Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx. The recall affects 17 units of the product, identified by Catalog 32-8105-029-00-29 and Lot 61722176.

The recall was initiated because the affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin. This component is part of the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit, where the ulnar and humeral components are connected by axis pins.

The affected products were distributed worldwide, including the USA, Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and the UK. Healthcare providers and facilities should stop using the affected lots and contact Zimmer for further instructions.

The recalled product

Product: Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: component-error
Affected units: 17

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)

Catalog 32-8105-029-00-29
Lot 61722176

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Zimmer, Inc.

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Same hazard · component error