Codman Cranial Hand Drill- Indicated when a craniotomy is required… — Class II medical device recall Z-1614-2023
Ongoing recall by Integra LifeSciences Corp., reported 2023-05-31. Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result
| Recall number | Z-1614-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2023-04-11 |
| Classified | 2023-05-19 |
| Reported by FDA | 2023-05-31 |
| Countries outside the US | AU, BE |
| Quantity | 337 units |
| UPC / GTIN / UDI-DI | 10381780520337 |
| Lot numbers | 6563961, 6568709, 6568710, 6568711, 6808685 |
| Model numbers | 82-6607 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1614-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.