Device recall

Z-0923-2013: Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis…

FDA device recall · Class II · Keystone Dental Inc

Key facts

Recall number (Z-number) Z-0923-2013
Recall event 64477
Product Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Product code NHA
Recalling firm Keystone Dental Inc
Recall class Class II
Status Terminated
Termination date Mar 11, 2013
510(k) numbers K101545
FEI number 3005990499

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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