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U.S. Department of Health and Human Services

Class 2 Device Recall CODMAN Cranial Hand Drill

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 Class 2 Device Recall CODMAN Cranial Hand Drillsee related information
Date Initiated by FirmApril 11, 2023
Date PostedMay 19, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1614-2023
Recall Event ID 92180
510(K)NumberK914479 
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
ProductCodman 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
Code Information UDI-DI: 10381780520337 Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information ContactLacey Gigante
609-212-9004
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionCodman 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
Quantity in Commerce337 units
DistributionPA Foreign: Australia, Belgium
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GWM
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