Class II — Acumed LLC
| Recalling firm | ACUMED LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 83 units distributed in the US |
| Distribution | distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico. |
| Initiated | 2016-12-05 |
| Classified | 2017-01-12 |
| Terminated | 2017-03-22 |
| Recall number | Z-1019-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Acumed LLC (Z-1019-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75904/
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