Device recall

Z-2389-2016: Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm…

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

Key facts

Recall number (Z-number) Z-2389-2016
Recall event 74719
Product Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a part of the following…
Product code HRS
Recalling firm Synthes (USA) Products LLC
Recall class Class II
Status Terminated
Termination date Feb 2, 2017
510(k) numbers K012114, K050110, K063049, K102694, K103243
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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