Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
Biomet, Inc. is recalling specific 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of infection from nonsterile implants, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants, specifically bone fixation screws, due to a defect in the sterile barrier packaging. The recall involves specific part numbers (HAA60-11030, HAA60-13030, HAA60-15040, HAA60-16040, HAA60-18040) and lot numbers (016150, 016210, 165130, 016230, 133890, 181600, 133970, 134000, 181620).
The FDA has classified this as a Class II recall. The issue is insufficient seal strength on the sterile barrier packaging, which could be jeopardized and cause the sterile barrier to be compromised. If the product becomes nonsterile and 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 facilities should check their inventory for the listed part and lot numbers and stop using these products if they match the recall criteria.
The recalled product
- Product
- Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
- Manufacturer
- Biomet, Inc.
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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