Device recall

Z-1057-2014: Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia…

FDA device recall · Class II · Synthes, Inc.

Key facts

Recall number (Z-number) Z-1057-2014
Recall event 67261
Product Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer…
Product code LXH
Recalling firm Synthes, Inc.
Recall class Class II
Status Terminated
Termination date Aug 18, 2016
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

Browse all FDA device recalls (products)