Recall Z-1614-2023— Integra LifeSciences Corp.

Name: FDA recall Z-1614-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-11

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2023-04-11. It names one FDA 510(k) clearance: K914479. 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: 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..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-11
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K914479 — MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCERCodman & Shurtleff, Inc.·cleared 1994-03-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.