Z-1614-2023 Class II Ongoing
FDA device recall Z-1614-2023 was initiated by Integra LifeSciences Corp. on April 11, 2023 and is designated Class II. 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, procedu… The recall status is ongoing. Affected quantity: 337 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2023
- Initiation Date
- April 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 337 units
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
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 Pattern
PA Foreign: Australia, Belgium
Code Information
UDI-DI: 10381780520337 Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710