Device recall

Z-1410-2021: Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct…

FDA device recall · Class II · K2M, Inc

Key facts

Recall number (Z-number) Z-1410-2021
Recall event 87565
Product Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
Product code HRS
Recalling firm K2M, Inc
Recall class Class II
Status Terminated
Termination date Aug 12, 2021
510(k) numbers K111439
FEI number 3008599177

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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