Codman Cranial Access Kit with Xylocaine recallZ-0706-2012 · Codman & Shurtleff, Inc. · initiated Oct 25, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Codman & Shurtleff, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial kits.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-0706-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 25, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Codman & Shurtleff, Inc.
- Quantity
- 861 units
- Product code
- GWM
- FDA submissions
- K914479
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of: Dubai, Mexico, Panama, Spain and Uruguay.
Product description
Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 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.
Code information (models, lots, serial numbers)
Lot codes: 10LD1378, 10LD3627
Other devices under the same FDA submission
9 devices cleared under K914479 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Codman Microsensor® 826631Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure75 reports
- CODMAN® 826607Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall2 reports
- CODMAN® 826614Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall1 report
- CODMAN® 826616Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 recall0 reports
- CODMAN MICROSENSOR 82-6631Cerenovus, Inc. · DEVICE, MONITORING, INTRACRANIAL PRESSURE14 reports
- Codman Microsensor® 826638Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure11 reports
- CODMAN MICROSENSOR 82-6638Cerenovus, Inc. · DEVICE, MONITORING, INTRACRANIAL PRESSURE6 reports
- CODMAN® 826612Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 report
- Codman Microsensor® 826632Integra Lifesciences Production Corporation · Device, monitoring, intracranial pressure1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 60362).
- Z-0707-2012 · TerminatedCodman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and th…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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