Device recall

Z-0121-2017: 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator…

FDA device recall · Class II · Synergetics Inc

Key facts

Recall number (Z-number) Z-0121-2017
Recall event 74918
Product 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Product/Part Number 70025SP, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
Product code HQE
Recalling firm Synergetics Inc
Recall class Class II
Status Terminated
Termination date Apr 27, 2017
510(k) numbers K121675
FEI number 1000119053

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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