The Recall Desk
ModerateFDA (Devices)·Z-0071-2014·Announced 2013-11-06

Zimmer Recalls Metasul Head Implants Due to Packaging Adhesion Issue

Zimmer, Inc. is recalling Metasul Head implants because the low-density polyethylene packaging bags adhere to the device surfaces.

What this means for you

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, which typically corresponds to a Moderate severity score (2) in the absence of reported injuries or hospitalizations, as the hazard is a packaging defect rather than a direct biological or structural failure.

Plain-English summary

Zimmer, Inc. is recalling 194 units of Metasul Head implants, intended for use in total hip arthroplasty. The recall is due to a packaging defect where the low-density polyethylene (LDPE) bags used to package the implants adhere to the highly polished surface of the devices.

The affected products are identified by Part Number Range 00-8770-040-01/05 & 01.01062.405/408. These devices were distributed worldwide, including in the United States and numerous international markets such as Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, and Mexico.

This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. No specific instructions for consumers are provided in the source text, but the recall is initiated by the manufacturer to address the packaging adhesion issue.

The recalled product

Product
Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implants
Hazard

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)

  • Part Number Range:00-8770-040-01/05 & 01.01062.405/408

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · packaging defect

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