Cranial perforators recalled as inadequate weld recall expands to smaller sizes
Integra LifeSciences is recalling 5,109 CODMAN Disposable Perforators, 9mm, extending an existing 14 mm recall for inadequate welds. The FDA has classified it Class I.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA classified this recall as Class I, which the rubric assigns the top severity regardless of other factors.
Plain-English summary
The CODMAN Disposable Perforator 9mm cranial perforator, model 261223, from Integra LifeSciences, is being recalled.
The action expands the recall of size 14 mm Codman Disposable Perforators for inadequate welds to the size 11 mm and 9 mm perforators, which the firm states is out of an abundance of caution.
The recall covers 5,109 units carrying UDI 10381780513605, across lots including 5828553, 6264478, 6264481, 6264482, 7230672, 7230673 and 7230674. Distribution was worldwide, including nationwide in the United States and to Argentina, Australia, Austria, the Bahamas and Barbados. The FDA has classified the recall as Class I, its most serious category, used where there is a reasonable probability of serious injury or death.
Facilities should quarantine affected lots immediately and follow Integra's instructions.
The recalled product
- Product
- CODMAN Disposable Perforator 9mm. Cranial Perforator.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- inadequate-weld
- class-i
- neurosurgery
- recall-expansion
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. 261223
- UDI: 10381780513605
- Lot No. 5828553
- 6264478
- 6264481
- 6264482
- 7230672
- 7230673
- 7230674
- 7230675
- 7261971
- 7268008
- 7268009
- 7268010
- 7268011
- 7268012
- 7268013
- 7268014
- 7268015
- 7268016
Distribution
Distributed nationwide across the United States.
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