The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1242-2014·Announced 2014-03-26

Biomet Recalls Intramedullary Bone Saw CAM Assembly Due to Labeling Error

Biomet, Inc. is recalling specific lots of the Intramedullary Bone Saw CAM Assembly because the Saw Blade Assembly was incorrectly identified as a CAM Assembly.

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 labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Biomet, Inc. is recalling Part 475620 Intramedullary Bone Saw CAM Assembly, Size 12mm. This clinical instrument is used to correct leg length or rotational discrepancies in the femur. The recall affects Lot 669420.

The recall was initiated due to incorrect labeling. The Saw Blade Assembly was identified as a CAM Assembly. The agency classifies this as a Class II recall.

The product was distributed worldwide, including nationwide in the United States to the states of New York, Texas, Michigan, and Minnesota, as well as to Australia and The Netherlands. Users should stop using the affected product and contact Biomet, Inc. for further instructions.

The recalled product

Product
Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
1

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)

  • Lot 669420

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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