[pending] CODMAN Disposable Perforator 11mm. Cranial Perforator.
Pending LLM rewrite. Source: FDA_DEVICE Z-0373-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
The recalled product
- Product
- CODMAN Disposable Perforator 11mm. Cranial Perforator.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No. 261222
- UDI: 10381780513612
- Lot No. 7221964
- 7221972
- 7221976
- 7221977
- 7221978
- 7221979
- 7221980
- 7221981
- 7221982
- 7221983
- 7221984
- 7221985
- 7221986
- 7221987
- 7221988
- 7221989
- 7221990
- 7221991
Distribution
Distributed nationwide across the United States.
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