FDA Recalls BIOSTOP G Cement Restrictor Due to Elevated Endotoxin Levels
DePuy Ireland is recalling all lots of BIOSTOP G Bioresorbable Cement Restrictor because endotoxin levels exceeded FDA regulatory guidance. Endotoxins can cause inflammatory responses, from mild fever to potential organ damage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with detected endotoxin contamination exceeding FDA regulatory guidance. No illnesses or injuries reported. The source identifies endotoxins as capable of causing inflammatory responses up to vital organ damage, meeting the risk-of-harm criteria in the rubric for a High severity rating.
Plain-English summary
BIOSTOP G Bioresorbable Cement Restrictor, manufactured by DePuy Ireland UC, is being recalled.
All lots are being recalled as a precautionary measure. Testing revealed endotoxin levels higher than current FDA regulatory guidance. Endotoxins have the potential to initiate inflammatory responses, ranging from mild fever to potential damage to vital organs.
No illnesses or injuries have been reported. Approximately 2,199 units were distributed in the US and 43,515 internationally.
Patients and healthcare providers who have this device should contact the manufacturer, DePuy Ireland UC, for return or replacement instructions.
The recalled product
- Product
- BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)
- Manufacturer
- Depuy Ireland UC
Distribution
Distributed nationwide across the United States.
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