Integra LifeSciences Corp. (NeuroSciences) — Class II: Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
Integra LifeSciences Corp. (NeuroSciences) initiated a Class II recall for Cytal Burn Matrix (10x15 cm, Product ID: BMM1015) due to an increased rate of out-of-specification endotoxin results.
This affects Integra LifeSciences Corp., clinical facilities utilizing the Cytal Burn Matrix, and quality/manufacturing personnel responsible for endotoxin testing and product release.
An increase in out-of-specification endotoxin results suggests potential lapses in manufacturing control or raw material screening. For implantable or wound-contact devices, elevated endotoxin levels can lead to pyrogenic responses or adverse clinical outcomes, likely necessitating a thorough investigation into the root cause within the production environment or supply chain.
Quality teams should immediately verify inventory for Product ID BMM1015, quarantine affected units, and review recent endotoxin testing logs to ensure no other batches exhibit similar out-of-specification trends. Regulatory departments should maintain documentation of the ongoing status of this recall for potential future inspectional inquiries.
Class II. Reason: Increased rate of out-of-specification endotoxin results.. Product: Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.. Firm: Integra LifeSciences Corp. (NeuroSciences) (Princeton NJ United States). Status: Ongoing.
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