HydroSet XT Injectable HA Bone Cement — Class II medical device recall Z-0678-2019
Terminated recall by Howmedica Osteonics Corp., reported 2019-01-02, distributed in CO, FL, GA, IA, MA, ME, MI, MN…. Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19
| Recall number | Z-0678-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Allendale, NJ, United States |
| Recall initiated | 2018-11-15 |
| Classified | 2018-12-22 |
| Reported by FDA | 2019-01-02 |
| Terminated | 2020-06-18 |
| Distributed | CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI, WV |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07613327064278 |
| Lot numbers | IC02595 |
| Model numbers | 897005 |
Product
HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
Reason for recall
Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19
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-0678-2019. 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.