Device recall

Z-2816-2020: DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm…

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

Key facts

Recall number (Z-number) Z-2816-2020
Recall event 86104
Product DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381
Product code HRS
Recalling firm Synthes (USA) Products LLC
Recall class Class II
Status Terminated
Termination date Feb 18, 2022
510(k) numbers K011335
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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