Cortoss Bone Augmentation Material — Class II medical device recall Z-1900-2020
Terminated recall by Howmedica Osteonics Corp., reported 2020-05-13, distributed in CA, CO, FL, GA, IL, IN, KS, MI…. Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if u
| Recall number | Z-1900-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Allendale, NJ, United States |
| Recall initiated | 2020-04-01 |
| Classified | 2020-05-05 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2020-08-27 |
| Distributed | CA, CO, FL, GA, IL, IN, KS, MI, OH, PA, TX, UT, VA, WA, WI |
| Quantity | 115 |
| UPC / GTIN / UDI-DI | 00808232000962, 00808232000979 |
| Lot numbers | 2101-0010, A1903054, A1906006, A1907006, A1908003 |
| Model numbers | 2101-0005, 2101-0010 |
Product
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Reason for recall
Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.
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-1900-2020. 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.