Biomet Recalls EBI XFIX DFS Rail System Due to Missing Markings
Biomet is recalling 49 units of the EBI XFIX DFS Rail System because graduation markings were missing on 14 swivel clamps.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves missing graduation markings, which is a labeling defect that could affect device usage but does not involve a high-risk pathogen or reported serious injury.
Plain-English summary
Biomet, Inc. is recalling 49 units of the EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The device is a unilateral external fixator used in the treatment of bone fractures. The recall is due to a report that number scale/graduation markings were missing on 14 pieces of the swivel clamp.
The affected products are identified by Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210). The devices were distributed worldwide, including in the United States (TX, TN, PA, CA, NY, FL, and MI) and in Japan and Columbia.
Healthcare providers and patients should stop using the affected devices and contact Biomet, Inc. for further instructions.
The recalled product
- Product
- EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 49
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)
- Catalog Number 06350 and Lot Number Identification 994790 (packaged as 042210)
Distribution
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