The Recall Desk
HighFDA (Devices)·Z-1605-2014·Announced 2014-05-21

Zimmer Hinged Knee Support Recalled Due to Latex Contamination

Zimmer, Inc. is recalling 546 units of Hinged Knee Supports 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 rubric criteria for 'High' severity (allergen mislabeling on common allergens) where no specific injuries or illnesses are reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling 546 units of Hinged Knee Supports (Model # 00-1773-002-00 through 00-1773-008-00). The product is intended to provide added lateral stability and allow the knee to tolerate more strenuous activity during recuperation.

The recall was initiated after the firm discovered, during a transfer of products from a recently shutdown facility, that raw material labeled as latex-free actually contained latex. The affected units were distributed worldwide, including in the United States and in Australia, Canada, Germany, Iraq, Italy, Saudi Arabia, Tunisia, and the United Arab Emirates.

Consumers with this product should stop using it and contact Zimmer, Inc. for further instructions. Individuals with a known latex allergy should be particularly cautious and consult a healthcare professional if they have used the product.

The recalled product

Product
Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Support
Hazard
Affected units
546

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 #: 00-1773-002-00 through 00-1773-008-00

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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