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Recall Observatory FDA recall evidence

Device product

Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607

Z-1614-2023

April 11, 2023

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 92180
Status
Ongoing
Classification
Class II
Quantity
337 units
Official record key
device-enforcement:Z-1614-2023

Official wording

Reason: Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.

Code information: UDI-DI: 10381780520337 Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710

Distribution pattern: PA Foreign: Australia, Belgium

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.