Device recall

Z-2240-2008: NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous…

FDA device recall · Class III · Nobel Biocare USA LLC

Key facts

Recall number (Z-number) Z-2240-2008
Recall event 48702
Product NobelReplace Tapered Groovy RP 4.3x10mm. These products are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to support for prosthetic devices.
Product code DZE
Recalling firm Nobel Biocare USA LLC
Recall class Class III
Status Terminated
Termination date Sep 22, 2008
510(k) numbers K050258, K050705
FEI number 1000125598

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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