Biomet Recalls Arthroscopes and Implants Due to Sterile Seal Defects
Biomet is recalling various trauma and sports medicine instruments and arthroscopes because insufficient seal strength on sterile packaging could allow the product to become nonsterile.
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 (infection from nonsterile implants) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants, including arthroscopes, due to a defect in the sterile barrier packaging. The recall involves specific part numbers 908518 and 908520, and lot numbers 675890, 579290, and 579300.
The issue is insufficient seal strength on the sterile barrier packaging. This defect could jeopardize the seal, compromising the sterile barrier and causing the product to become nonsterile. If a nonsterile product is used or implanted, it may lead to an infection.
The affected products were distributed worldwide, including nationwide in the United States and in countries such as 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 products and contact Biomet for further instructions.
The recalled product
- Product
- Various trauma and sports medicine instruments and implants. Arthroscope.
- Manufacturer
- Biomet, Inc.
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 908518 908520 Lot #'s 675890 579290 579300
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.
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