The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1824-2016·Announced 2016-06-01

Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

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 infection from non-sterile medical devices, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Biomet, Inc. is recalling various trauma and sports medicine instruments and implants, specifically identified as Passer, due to a defect in the sterile barrier packaging. The recall is being conducted because the seal strength on the packaging is insufficient, which could jeopardize the seal and compromise the sterile barrier. If the product becomes non-sterile and is subsequently used or implanted, it may lead to an infection.

The affected products are identified by Part # 904051 and Lot # 880370 or 673790. These items were distributed nationwide in the United States and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, The Netherlands, Japan, Korea, Malaysia, Mexico, and Peru.

Healthcare providers and consumers should stop using these specific instruments and implants immediately. Users should check their inventory for the listed part and lot numbers and contact Biomet, Inc. for further instructions on how to return or dispose of the affected products.

The recalled product

Product
Various trauma and sports medicine instruments and implants. Passer.
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Instruments
Hazard

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)

  • Part #'s 904051 Lot #'s 880370 673790

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 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 14 products in this recall →

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