The Recall Desk
HighFDA (Devices)·Z-1604-2014·Announced 2014-05-21

Zimmer Cartilage Knee Brace Recalled Due to Latex Contamination

Zimmer, Inc. is recalling 2,222 units of Cartilage Knee Braces because raw material labeled as latex-free actually contained latex.

What this means for you

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 high-risk allergen (latex) mislabeling on a medical device, which fits the 'High' severity criteria for allergen mislabeling on common allergens.

Plain-English summary

Zimmer, Inc. is recalling 2,222 units of Cartilage Knee Braces, model numbers 00-1747-001-00 through 00-1747-005-00. These medical devices are used in the treatment and support of various knee injuries or following surgical and nonsurgical correction.

The recall was initiated after the firm discovered that raw material labeled as latex-free actually contained latex during a product transfer from a recently shutdown facility. This labeling error poses a risk to patients with latex allergies.

The affected products were distributed worldwide, including in the United States and several international countries. Consumers and healthcare providers should stop using these specific model numbers and contact Zimmer, Inc. for instructions on return or replacement.

The recalled product

Product
Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Support
Hazard
Affected units
2,222

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 (1)

  • Model #: 00-1747-001-00 through 00-1747-005-00

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · latex allergy

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