Device recall

Z-0973-2013: PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog…

FDA device recall · Class II · Keystone Dental Inc

Key facts

Recall number (Z-number) Z-0973-2013
Recall event 64633
Product PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
Product code NDP
Recalling firm Keystone Dental Inc
Recall class Class II
Status Terminated
Termination date Sep 26, 2013
510(k) numbers K051614
FEI number 3005990499

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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