Biostop G Bioresorbable Cement Restrictor
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
---|---|---|
Biostop G Bioresorbable Cement Restrictor |
All lots. |
546314000 |
Issue
All lots of Biostop G Bioresorbable Cement Restrictor are being removed as a precautionary measure because recent in vitro testing of endotoxin levels from a sample restrictor fully dissolved in solution were calculated at >20,000 endotoxin units (eu)/device over 24 hours, based on restrictor size. This exceeds the recommended value of 20 eu/device over 1 hour as referenced in the current FDA regulatory guidance.
Recall start date: December 21, 2022
Additional information
Details
Depuy Ireland Uc
Loughbeg, Ringaskiddy, Cork, Ireland
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