Device recall

Z-0871-2026: Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

FDA device recall · Class II · Paragon 28, Inc.

Key facts

Recall number (Z-number) Z-0871-2026
Recall event 97891
Product Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Product code HSB
Recalling firm Paragon 28, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K234128
FEI number 3008650117

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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