BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 1
Summary
The FDA issued a Class II for BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8) by Depuy Ireland UC. Reason: All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than re.
Details
Source
Device Recall
External ID
Z-0951-2023
Action Date
2023-01-18
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: Catalog Number Part Description UDI/DI * 546308000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 8 10603295174547 546310000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 10 10603295174554 546312000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 12 10603295174561 546314000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 14 10603295174578 546316000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 16 10603295174585 546318000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 18 10603295174592 546320000 BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR SIZE 20 10603295174608 * UDI-DI on GS1 0603295a0035792 Expiry dates December 2022 thru May 2025 ALL LOTS
Quantity Affected: 2199 US; 43515 OUS
Reason for Recall
All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.
Distribution
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Latvia, Lebanon, Luxemburg, Mexico, Netherlands, New Zealand, Norway, Portugal, Reunion, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, and Uruguay.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-19
Company
Co. Cork Munster
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Depuy Ireland UC has 36 FDA actions in our database, including 1 recall and 35 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Depuy Ireland UC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Depuy Ireland UC have FDA actions?
Depuy Ireland UC has 36 FDA actions in our database, including 1 recall and 35 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0951-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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