BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 — Class II medical device recall Z-0951-2023
Ongoing recall by Depuy Ireland UC, reported 2023-01-18, distributed nationwide. All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tes
| Recall number | Z-0951-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Depuy Ireland UC, Co. Cork Munster, Ireland |
| Recall initiated | 2022-12-19 |
| Classified | 2023-01-12 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HR, HU, IE, IL, IT, LB, LV, MX, NL, NO, NZ, PT, RO, RU, SE, SK, UY, ZA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10603295174547, 10603295174554, 10603295174561, 10603295174578, 10603295174585, 10603295174592, 10603295174608 |
| Model numbers | 546308000 |
| Expiration dates | 2022-12-20 |
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)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0951-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.