—#199831

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

FDA product code: GWM — Device, Monitoring, Intracranial Pressure
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K914479
Affected lot / code info: UDI-DI: 10381780520337 Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: PA Foreign: Australia, Belgium

Timeline

Recall initiated: 2023-04-11
Posted by FDA: 2023-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199831. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.