Z-1614-2023Class II

Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure...

Name: Z-1614-2023 Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure...
Creator: Integra LifeSciences Corp.
Published: 2023-04-11
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2023-04-11 / Open, Classified

FDA source

Integra LifeSciences Corp. began a recall of Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid... on 2023-04-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1614-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-11
Posted: 2023-05-19
Recalling firm: Integra LifeSciences Corporation
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
Product code: GWM Device, Monitoring, Intracranial Pressure
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 root cause: Under Investigation by firm
Action: 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 [email protected] 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: [email protected]
Quantity in commerce: 337 units
Distribution: PA Foreign: Australia, Belgium
Product codes and lots: UDI-DI: 10381780520337 Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1614-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1614-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-19

Product code GWM

K914479Class IIMicrosensor Intracranial Pressure TransducerCodman & Shurtleff, Inc. / cleared 1994-03-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)