Integra LifeSciences Corp.: Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage dev

Hazard

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.

Details from the source

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. Distribution: PA Foreign: Australia, Belgium Quantity: 337 units Lot/code info: UDI-DI: 10381780520337 Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710

UPC codes

10381780520337

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.