Device recall

Z-0369-2014: Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium…

FDA device recall · Class II · Synthes USA HQ, Inc.

Key facts

Recall number (Z-number) Z-0369-2014
Recall event 66552
Product Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and…
Product code HSB
Recalling firm Synthes USA HQ, Inc.
Recall class Class II
Status Terminated
Termination date Aug 18, 2016
510(k) numbers K070294
FEI number 3005180112

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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