Device recall

Z-0716-2011: SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g…

FDA device recall · Class II · Patterson Dental Supply, Inc.

Key facts

Recall number (Z-number) Z-0716-2011
Recall event 57242
Product SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package…
Product code EBF
Recalling firm Patterson Dental Supply, Inc.
Recall class Class II
Status Terminated
Termination date Sep 11, 2012
510(k) numbers K013647
FEI number 2183301

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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