Overview of recall records associated with Integra LifeSciences Corp. (NeuroSciences), including dates, categories and classifications where available.
Classification mix: Class II: 17, Class I: 8.
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes,…
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Software issue that renders the touch screen unresponsive.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Potential packaging failures, which could lead to a breach in the sterile barrier.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
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.
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.
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet…
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Packaging failures were identified which could lead to a breach in the sterile barrier.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Lack of sterility assurance.
Inadequate weld that can potentially cause the product to disassemble.
This page summarizes recall records in which the official source identifies Integra LifeSciences Corp. (NeuroSciences) as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
