The Recall Desk
ModerateFDA (Devices)·Z-0935-2014·Announced 2014-02-12

Zest Anchors Recalls Locator Implant Attachment Systems Due to Labeling Error

Zest Anchors is voluntarily recalling specific lots of Locator Implant Attachment Systems because the product labels incorrectly state the final torque for the abutment.

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 involves a labeling error regarding torque specifications. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries are classified as Moderate.

Plain-English summary

Zest Anchors, LLC is voluntarily recalling specific lots of the Locator Implant Attachment System. The recall is being conducted because the product is currently provided with a label that indicates the final torque applied to the abutment should be 30 N-cm. The company recently noted that this labeling does not reflect the optimal performance parameters required to increase the factor of safety between the failure load of the abutment screw and the recommended specifications.

The affected products are universal hinge, resilient attachments designed for use with overdentures or partial dentures retained by endosseous implants in the mandible or maxilla. A total of 3,130 units were distributed in Ohio and Switzerland. The recall includes specific part numbers and lot numbers, which are listed in the official FDA recall notice Z-0935-2014.

Because the Locator Implant Attachment System is not sold by Zest Anchors as a sterilized product, it does not have a designated shelf-life. Healthcare professionals and patients should verify the lot numbers of their devices against the official recall list. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by end
Manufacturer
Zest Anchors LLC
Affected units
3,130

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 (20)

  • Part Numbers: 8875-SPI
  • 8875-SPI-TMS
  • 8876-SPI
  • 8876-SPI-TMS
  • 08877-SPI
  • 08877-SPI-TMS
  • 08878-SPI
  • 08878-SPI-TMS
  • 08879-SPI
  • 08880-SPI
  • Lot Numbers: 11052
  • 15306
  • 20665
  • 21351
  • 12025
  • 12259
  • 22440
  • I0K7X
  • I0K7Y
  • 11963

Distribution

Distributed in 1 state:

Same manufacturer · Zest Anchors LLC

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