Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects
Biomet 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-harm product (infection from nonsterile implants) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Biomet, Inc. is recalling various trauma and sports medicine instruments and implants, including appliances, fixation devices, and nail/blade/plate combinations. The recall is due to insufficient seal strength on the sterile barrier packaging. This defect could jeopardize the seal, causing the sterile barrier to be compromised and the product to become nonsterile.
The affected products were distributed nationwide in the United States and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, The Netherlands, Japan, Korea, Malaysia, and Mexico. Specific part numbers involved in the recall are 200185, 200195, 200200, and 16-235136. The affected lot numbers are 711680, 655630, 691980, 722690, 692000, 722670, and 744670.
If the product becomes nonsterile and is used or implanted, it may lead to an infection. Healthcare providers and facilities should check their inventory for these specific part and lot numbers and stop using the affected devices. Consumers who have had these products implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
- 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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