CLASS II Device recall · Reported 30 Mar 2022 · FDA Enforcement Report
Codman Cranial Access Kits- indicated when a craniotomy is recalled
Integra LifeSciences is recalling Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an, distributed nationwide in the US. The recall was initiated on 21 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0817-2022
- FDA event ID
- 89618
- Recalling firm
- Integra LifeSciences, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2022
- FDA classified
- 22 Mar 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 21 Jan 2022 | Recall initiated by company | |
| 22 Mar 2022 | Classified by FDA | +60 days |
| 30 Mar 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
Product as listed by the FDA
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614
Where it was distributed
Worldwide distribution - US Nationwide and the country of Hong Kong.
Questions about this recall
Is Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an recalled?
Yes. Integra LifeSciences recalled Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an on 21 Jan 2022. The recall is Class II and its status is Terminated. Recall number Z-0817-2022.
Why was it recalled?
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
Which lots are affected?
Lot Numbers: 20LDC222, 21HDC461 UDI# 10381780520375
Where was it sold?
Worldwide distribution - US Nationwide and the country of Hong Kong.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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