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Biostop g bioresorbable cement restrictor
Official notice
5 Jan 2023
Last checked
5 Jan 2023
An official Health Canada notice concerns Biostop g bioresorbable cement restrictor. 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 Published 2023-01-05.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72529
Official notice
2023-01-05
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Turn on recall alertsAffected products
Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Depuy Ireland Uc, Biostop G Bioresorbable Cement Restrictor.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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