A&E Medical Thorecon Plating System Kits Recalled for Molding Defect
Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the tensioners inoperable.
What this means for you
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, and the defect renders the device inoperable without explicit reports of injury or hospitalization, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Alto Development Corp is recalling 209 units of A&E Medical Thorecon Plating System Kits, Model No. 94-1500-04-S. These medical devices are used for fracture fixation or reconstruction of the sternum.
The recall is due to a molding defect in some Thorecon disposable tensioners supplied in the kits. This defect occludes the through-channel for cable tensioning, which renders the tensioner inoperable.
The affected products were distributed to Alabama, California, Florida, Georgia, Illinois, Louisiana, Missouri, Oklahoma, Mississippi, New Mexico, South Carolina, Texas, Utah, Vermont, Washington, and Wisconsin. The code information for the recalled items is 327144.
The recalled product
- Product
- A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum.
- Manufacturer
- Alto Development Corp
- Category
- Medical Device — Orthopedic
- Hazard
- Affected units
- 209
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)
- 327144
Distribution
Part of a larger recall action
This product is one of 5 recalled by Alto Development Corp 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.
See all 5 products in this recall →Related recalls
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