The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0246-2020·Announced 2019-11-06

FDA 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 FDA classified this as a Class II recall. The defect renders the device inoperable, which is a significant functional failure, but the source text does not report any injuries, illnesses, or deaths, placing it in the moderate category for a medical device with no reported harm.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Alto Development Corp's Thorecon Plating System Kits, Model No. 94-1700-10. These kits are used for fracture fixation or reconstruction of the sternum. A total of 209 units are affected by this recall.

The recall was initiated because some Thorecon disposable tensioners supplied in the kits exhibit a molding defect. This defect occludes the through-channel used for cable tensioning, which renders the tensioner inoperable. The affected lots are identified by the following codes: 327150, 327151, 327152, 327707, 340284, 343232, and 343236.

The affected products were distributed to facilities in Alabama, California, Florida, Georgia, Illinois, Louisiana, Missouri, Oklahoma, Mississippi, New Mexico, South Carolina, Texas, Utah, Vermont, Washington, and Wisconsin. Healthcare providers and facilities should check their inventory for these specific lot codes and discontinue use of the affected kits.

The recalled product

Product
A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. 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 (7)

  • 327150
  • 327151
  • 327152
  • 327707
  • 340284
  • 343232
  • 343236

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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