The Recall Desk
HighFDA (Devices)·Z-0474-2013·Announced 2012-12-12

Biomet Recalls Bio-Modular Humeral Heads Due to Missing Ion Implantation

Biomet, Inc. is recalling four Bio-Modular Humeral Heads because they are missing the ion implantation feature, which may cause increased wear and shorter implant life.

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 is classified as FDA Class II and involves a risk-of-harm product (orthopedic implant) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Biomet, Inc. is recalling four units of the Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant). The affected units are identified by Catalog Number 113740 and Lot Number 779270. The recall is limited to units distributed in Wisconsin.

The recall is being issued because the items in this lot are missing the ion implantation feature. As a result, the surface of the humeral head may be softer and more prone to scratching. This condition could potentially cause higher wear of the poly bearing, which in turn could lead to a shorter implant life.

The source text does not specify instructions for consumers or patients regarding the recall. The agency classification for this recall is Class II.

The recalled product

Product
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
4

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)

  • Catalog Number: 113740 and Lot Number Identification: 779270

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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