Device recall

Z-1318-2015: DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal…

FDA device recall · Class II · In2Bones, SAS

Key facts

Recall number (Z-number) Z-1318-2015
Recall event 70736
Product DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
Product code HWC
Recalling firm In2Bones, SAS
Recall class Class II
Status Terminated
Termination date May 19, 2016
510(k) numbers K132912
FEI number 3010470577

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

Browse all FDA device recalls (products)