OPT Croutons is a synthetic bone substitute designed for the repair… — Class II medical device recall Z-1019-2017
Terminated recall by Acumed LLC, reported 2017-01-18, distributed in FL, IN, KS, MI, MO, NE, OH, PA…. OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the steriliz
| Recall number | Z-1019-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acumed LLC, Hillsboro, OR, United States |
| Recall initiated | 2016-12-05 |
| Classified | 2017-01-12 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-03-22 |
| Distributed | FL, IN, KS, MI, MO, NE, OH, PA, TX |
| Quantity | 83 units |
| Lot numbers | 549/12.001 |
| Model numbers | 65-0210-S |
Product
OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt.
Reason for recall
OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum dose required per the new performance qualification.
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-1019-2017. 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.