Device recall

Z-0351-2010: Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics…

FDA device recall · Class II · Orthopediatrics Corp

Key facts

Recall number (Z-number) Z-0351-2010
Recall event 52852
Product Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Rt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-037. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic…
Product code HSB
Recalling firm Orthopediatrics Corp
Recall class Class II
Status Terminated
Termination date Oct 25, 2010
510(k) numbers K083726
FEI number 3006460162

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

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