Biostop G Bioresorbable Cement Restrictor
Brand(s)
Last updated
Summary
Product
Biostop G Bioresorbable Cement Restrictor
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| Biostop G Bioresorbable Cement Restrictor | All lots. | 546314000 546308000 546316000 546320000 546310000 546312000 546318000 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies
Depuy Ireland Uc
Loughbeg, Ringaskiddy, Cork, Ireland
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72529
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