Recall Z-1614-2023 ยท GWM Device, Monitoring, Intracranial Pressure
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
| Date | May 19, 2023 (initiated Apr 11, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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 FCA2@integralife.com i. or FAX to 1-609-7 |
| Quantity | 337 units |
| Distribution | PA Foreign: Australia, Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914479 | MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER Codman & Shurtleff, Inc., Mar 7, 1994 |