The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0623-2021·Announced 2020-12-23

Biomet OSS Polyethylene Tibial Bushing Recalled for Sterile Seal Breach

Biomet is recalling specific lots of OSS Polyethylene Tibial Bushings because a breach in the sterile seal could lead to loss of sterility.

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 3/5 (High).

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, which aligns with the High severity criteria.

Plain-English summary

Biomet, Inc. is recalling specific lots of OSS Polyethylene Tibial Bushings, Item number 150476. The product is intended for use in limb salvage. The recall involves 7,428 units distributed worldwide, including the United States, Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, EMEA, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, and Taiwan.

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 lots are 059680, 542010, and 542020.

Healthcare providers and patients should check their inventory and records for the affected item number and lot numbers. If the product is found, it should be removed from use and returned to Biomet, Inc. in accordance with the recall instructions.

The recalled product

Product
OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
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)

  • Lots 059680 542010 542020

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 →

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