Device recall

Z-1574-2016: 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID #…

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

Key facts

Recall number (Z-number) Z-1574-2016
Recall event 73770
Product 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Product code HWC
Recalling firm Synthes (USA) Products LLC
Recall class Class II
Status Terminated
Termination date Sep 2, 2016
510(k) numbers K041533
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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