BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12);
FDA device recall Z-0951-2023 · posted 2023-01-12 · Open, Classified
Recall details
- Recalling firm
- Depuy Ireland UC
- 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.
- Action taken
- On December 19, 2022, the firm notified affected consignees through "Urgent Medical Device Recall" letters. Customers were instructed to immediately identify and quarantine affected product in inventory. Recalled products should not be used. Customers should then contact Sedgwick at synthes5716@sedgwick.com or call 888-597-5387 to coordinate the return/credits of the subject products.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LZN
- Quantity affected
- 2199 US; 43515 OUS
- 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,
- Date initiated
- 2022-12-19
- Date posted
- 2023-01-12
- Location
- Ringaskiddy Co. Cork, Munster, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOSTOP G BONE CEMENT RESTRICTOR (K943727) | Landos, Inc. | 1995-05-11 |