Device recall

Z-1800-2015: 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws;. the…

FDA device recall · Class II · Synthes, Inc.

Key facts

Recall number (Z-number) Z-1800-2015
Recall event 71276
Product 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.
Product code HWC
Recalling firm Synthes, Inc.
Recall class Class II
Status Terminated
Termination date Aug 18, 2016
510(k) numbers K000684, K050683
FEI number 3005180112

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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