FDA Medical Device Recalls (openFDA)
Codman & Shurtleff, Inc.: Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult Product Code:80-1196 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.
- Recall number
- Z-0709-2012
- Recalling firm
- Codman & Shurtleff, Inc.
- Product
- Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw,, Adult Product Code:80-1196 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xylocaine) to allow physicians to access the cranium for various Neurosurgical procedures.
- Status
- Terminated
- Initiated
- 2011-10-25
- Posted
- 2012-01-11
- Terminated
- 2015-05-29
- Reason
- Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
- Root cause
- Labeling Change Control
- Action
- Codman issued an Urgent Medical Device Correction Notice dated October 25, 2011 to all affected customers. The notice identified the product, problem, and actions to be taken. Customers were instructed to notify all appropriate personnel of the correction notice. The notice instructs customers to fax the attached acknowledgement form to 508-977-6403. For questions call your Customer Service or contact your local Codman representative.
- Quantity
- 462 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.
- Lot, serial or model codes
- Lot codes: 449269 459957 BY254 FA247 KA209 LB283
- 510(k) numbers
- ["K853770"]
- PMA numbers
- not on file
- Product code
- GWM
- Firm FEI
- 3002947440
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28