The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1122-2015·Announced 2015-02-25

Biomet Recalls Specific Lot of Mallory Head Acetabular Shell Components

Biomet is recalling 17 units of the Mallory Head 4 Finned Acetabular Shell 50 mm (Lot 364600) due to a packaging mix-up with a different shell size.

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 2/5 (Moderate).

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, but the source text identifies the cause as a packaging mix-up without reporting any injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Biomet, Inc. is recalling 17 units of the Mallory Head 4 Finned Acetabular Shell 50 mm, Product Number 13-104150, Lot 364600. The recall was initiated following a mix-up in packaging between this product and the Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840).

The affected devices were distributed in the states of Virginia and Texas, as well as in Japan. These components are used in hip prostheses.

Healthcare providers and patients should check their inventory and records for this specific lot number. If the product is found, it should be removed from use and returned to Biomet, Inc. according to their instructions.

The recalled product

Product
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
17

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: 13-104150 Lot Number Identification: 364600

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Biomet, 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 →

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