The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0244-2020·Announced 2019-11-06

Alto Development Recalls Thorecon Plating System Kits Due to 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 reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Alto Development Corp is recalling 209 units of A&E Medical Thorecon Plating System Kits, Model No. 94-1400-04. These kits are intended 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 specific lot codes associated with the recall are 327705, 327706, 330587, 330588, 330753, 334396, 345417, and 345418.

The recalled product

Product
A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. 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 (8)

  • 327705
  • 327706
  • 330587
  • 330588
  • 330753
  • 334396
  • 345417
  • 345418

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 →

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