INFUSE — Class II medical device recall Z-1590-2013
Terminated recall by Medtronic Sofamor Danek USA Inc, reported 2013-07-03, distributed nationwide. Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a
| Recall number | Z-1590-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA Inc, Memphis, TN, United States |
| Recall initiated | 2013-05-28 |
| Classified | 2013-06-25 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2014-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, HK, IN, MX, NL, PA, PY |
| Quantity | 8,884 units |
| Reason classes | sterility |
| Lot numbers | 111064AAT, M111063AAA, M111063AAB, M111064AAE, M111064AAF, M111064AAI, M111064AAJ, M111064AAR, M111064AAS, M111064AAU, M111064AAX |
| Model numbers | 7510400 |
Product
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
Reason for recall
Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
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-1590-2013. 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.