Device recall

Z-0631-2011: 1.5 mm Inion CPS Baby, 20 hole plate, REF PLT-1001, sterile, Manufacturer…

FDA device recall · Class II · Stryker Craniomaxillofacial Division

Key facts

Recall number (Z-number) Z-0631-2011
Recall event 55861
Product 1.5 mm Inion CPS Baby , 20 hole plate, REF PLT-1001, sterile, Manufacturer, INION Oy, Finland.
Product code JEY
Recalling firm Stryker Craniomaxillofacial Division
Recall class Class II
Status Terminated
Termination date Jun 6, 2012
510(k) numbers K010351, K010352
FEI number 3005101424

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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

Browse all FDA device recalls (products)