Device recall

Z-2138-2016: Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

FDA device recall · Class II · Synthes (USA) Products LLC

Key facts

Recall number (Z-number) Z-2138-2016
Recall event 74418
Product Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue
Product code MBI
Recalling firm Synthes (USA) Products LLC
Recall class Class II
Status Terminated
Termination date Apr 25, 2017
510(k) numbers K994364
FEI number 3008812560

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)