Device recall

Z-1653-2010: Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical…

FDA device recall · Class II · Blackstone Medical, Inc.

Key facts

Recall number (Z-number) Z-1653-2010
Recall event 55002
Product Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.
Product code KWQ
Recalling firm Blackstone Medical, Inc.
Recall class Class II
Status Terminated
Termination date Sep 9, 2011
510(k) numbers K050892
FEI number 3001238051

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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