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 device. Part Number: 82-6607 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Integra LifeSciences Corp.
Lot Codes / Batch Numbers
UDI-DI: 10381780520337 Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710
Products Sold
UDI-DI: 10381780520337 Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710
Integra LifeSciences Corp. is recalling Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial due to Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PA
Page updated: Jan 10, 2026