Device recall

Z-0676-2012: Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This…

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

Key facts

Recall number (Z-number) Z-0676-2012
Recall event 60406
Product Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical instrument is a non powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Product code HTW
Recalling firm Synthes USA (HQ), Inc.
Recall class Class II
Status Terminated
Termination date Apr 16, 2015
FEI number 3005180112

At a glance

  • None 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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