The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0243-2020·Announced 2019-11-06

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.

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, 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
Category
Medical Device — Orthopedic Implant
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

Distributed in 16 states:

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

Same manufacturer · Alto Development Corp

See all →

Same hazard · device malfunction

See all →

Similar recalls