Actifuse ABX/Actifuse MIS System A bone void filler intended only for… — Class II medical device recall Z-1922-2016
Terminated recall by Apatech Limited, reported 2016-06-15, distributed nationwide. Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products
| Recall number | Z-1922-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apatech Limited, Elstree, N/A, United Kingdom |
| Recall initiated | 2015-08-18 |
| Classified | 2016-06-07 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2018-05-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IT, KW, MX, NL, NO, NZ, SE, SI, TW |
| Quantity | 11,696 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00506005078070 |
| Expiration dates | 2015-08-01 |
Product
Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
Reason for recall
Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.
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-1922-2016. 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.