[pending] CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator
Pending LLM rewrite. Source: FDA_DEVICE Z-1717-2025.
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
Inadequate weld that can potentially cause the product to disassemble.
The recalled product
- Product
- CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
- 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. 261230
- UDI: 10381780513629
- Lot No. Lot Number
- 5984530
- 7062002
- 7062006
- 7062013
- 7062014
- 7255930
- 7255931
- 7255932
- 7255933
- 7255934
- 7255935
- 7255936
- 7255937
- 7269522
- 7269523
- 7269524
- 7269525
Distribution
Distributed nationwide across the United States.
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