The Recall Desk
HighFDA (Devices)·Z-0622-2021·Announced 2020-12-23

Biomet M/H Modular Stem Recalled for Potential Sterile Seal Breach

Biomet, Inc. is recalling 7,428 units of the M/H Modular Stem (Item 13-104756) because a breach in the sterile seal could lead to loss of sterility.

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 involves a risk-of-harm product (loss of sterility) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Biomet, Inc. is recalling 7,428 units of the M/H Modular Stem, Item number 13-104756, intended for use in limb salvage procedures. The recall is due to a potential breach in the sterile seal of the packaging. A breach in the packaging seal could lead to a loss of sterility of the device.

The affected product is identified by Lot number 832990. The devices were distributed worldwide, including in the United States, Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, EMEA, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, and Taiwan.

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

The recalled product

Product
M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
7,428

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 number 832990

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 16 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 16 products in this recall →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · loss of sterility

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