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 disposable 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. 94-1300-04-S. These kits are used for fracture fixation or reconstruction of the sternum. The recall involves specific disposable tensioners supplied within the kits.
The recall is due to a molding defect in some of the tensioners. This defect occludes the through-channel required 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.
Healthcare providers and facilities should stop using the affected kits and contact Alto Development Corp for instructions on return or replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum.
- Manufacturer
- Alto Development Corp
- 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 (4)
- 327703
- 327704
- 330464
- 344282
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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See all →- ModerateA&E Medical Thorecon Plating System Kits Recalled for Molding Defect
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