The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1243-2014·Announced 2014-03-26

Biomet Recalls Intramedullary Bone Saw Cam Assemblies Due to Labeling Error

Biomet is recalling 10 Intramedullary Bone Saw Cam Assemblies because they were incorrectly labeled as Saw Blade Assemblies.

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 and involves a minor labeling error with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Biomet, Inc. is recalling 10 units of the Intramedullary Bone Saw, Cam Assembly, Size 13 mm (Part 475625). The recall is due to incorrect labeling where the Saw Blade Assembly was identified as a CAM Assembly. The Intramedullary Bone Saw is a clinical instrument used to correct leg length or rotational discrepancies in the femur.

The affected units are from lots 239430 and 239450. These products were distributed worldwide, including nationwide in the United States to New York, Texas, Michigan, and Minnesota, as well as to Australia and The Netherlands.

Healthcare facilities and consumers should stop using the affected products and contact Biomet, Inc. for further instructions.

The recalled product

Product
Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
10

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 (2)

  • Lot 239430
  • 239450

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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