Agency classClass IIOur severity:High FDA (Devices)·Z-0537-2013·Announced 2012-12-26

Zimmer Recalls Coonrad/Morrey Total Elbow Replacement Sets Due to Pin Error

Zimmer, Inc. is recalling specific lots of Coonrad/Morrey Total Elbow Replacement Sets 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 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 involves a risk-of-harm medical device where a component error could affect surgical outcomes, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Zimmer, Inc. is initiating a lot-specific recall of 23 units of the Coonrad/Morrey Total Elbow Elbow Component Replacement Set. The recall affects Catalog 32-8106-000-03, Lot 61644802. The product is a sterile medical device used for total elbow replacement surgery.

The recall was initiated because the affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin. This error affects the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit. The incorrect pin size may impact the proper articulation of the elbow components.

The affected products were distributed worldwide, including the United States, Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and the UK. Healthcare providers and facilities should check their inventory for the specific lot number and stop using the affected units. Patients who have already had the device implanted should contact their surgeon or Zimmer, Inc. for further instructions.

The recalled product

Product: COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: component-error
surgical-complication
Affected units: 23

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 32-8106-000-03
Lot 61644802

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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