Device recall

Z-0252-2007: BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0…

FDA device recall · Class III · BioHorizons Implant Systems Inc

Key facts

Recall number (Z-number) Z-0252-2007
Recall event 36764
Product BioHorizons Maximus 3.0 surgical kit, also marketed as BioHorizons One-piece 3.0 Implants and Surgical Kit
Product code DZE
Recalling firm BioHorizons Implant Systems Inc
Recall class Class III
Status Terminated
Termination date Aug 11, 2007
510(k) numbers K041938
FEI number 1000592496

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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