Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monit

FDA device recall Z-1614-2023 · posted 2023-05-19 · Open, Classified

Recall details

Recalling firm

Integra LifeSciences Corp.

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.

Action taken

Codman issued Urgent Medical Device Recall Letter on 4/11/23 via Fed'X. Letter states reason for recall, health risk and action to take: 1. If you do have units of the affected product listed in Table 1, remove them immediately from service. 2. If you do have affected product, check the box on the enclosed form I do have affected product. Record the total quantity of the affected product that you have. 3. If you do not have affected product, check the box, I do not have affected product. 4. Complete the attached Acknowledgement Form and return to FCA2@integralife.com i. or FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. 6. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. A credit or alternative replacement can be placed for the quantity noted on the form. Receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. We recommend you also maintain a copy of this notification and signed copy of the acknowledgement form for your records. Regulatory agencies such as the FDA perform audits of field actions of this nature to verify that customers have been notified and understand the nature of the field action. Should you have any questions regarding these instructions, please contact your Integra Sales Representative or Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GWM

Quantity affected

337 units

Distribution

PA Foreign: Australia, Belgium

Date initiated

2023-04-11

Date posted

2023-05-19

Location

Princeton, NJ

Related 510(k) clearances