Miami Device Solutions Recalls Right Proximal Humerus Plates Due to Identification Error
Miami Device Solutions is recalling 15 units of Right Proximal Humerus Plates because they may be improperly identified as left.
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, but the source text describes a labeling/identification error without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Miami Device Solutions, LLC. is recalling 15 units of Right Proximal Humerus Plates, 8 holes, Right, REF MDS130108R. The recall is due to a labeling error where the product component parts may be improperly identified as left.
The affected products are intended to provide internal fixation of fractures of the proximal humerus. The recall covers units distributed nationwide in Florida, Rhode Island, Massachusetts, Pennsylvania, New York, Ohio, Georgia, Washington, Alabama, California, Texas, and Virginia.
Healthcare providers and facilities should check their inventory for the specific lot number PM00208 and stop using any affected units. They should contact Miami Device Solutions for further instructions on the recall.
The recalled product
- Product
- Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +…
- Manufacturer
- Miami Device Solutions, LLC.
- Hazard
- Affected units
- 15
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)
- Lot number PM00208
Distribution
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