Device recall

Z-0604-2018: 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile

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

Key facts

Recall number (Z-number) Z-0604-2018
Recall event 78958
Product 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
Product code HSB
Recalling firm Synthes (USA) Products LLC
Recall class Class II
Status Terminated
Termination date Jul 10, 2018
510(k) numbers K011857
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

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