Device recall

Z-0091-2027: Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF…

FDA device recall · Class II · Onkos Surgical, Inc.

Key facts

Recall number (Z-number) Z-0091-2027
Recall event 99692
Product Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Product code LPH
Recalling firm Onkos Surgical, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K212815, K223348
FEI number 3013450937

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

Browse all FDA device recalls (products)