Integra LifeSciences Corp.: Medical Device Recall in 2023 - (Recall #: Z-1614-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 11, 2023

Date Posted: May 31, 2023

Recall Number: Z-1614-2023

Event ID: 92180

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 337 units

Code Information:

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

Distribution Pattern:

PA Foreign: Australia, Belgium

Voluntary or Mandated:

Voluntary: Firm initiated