CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report
OPT Croutons is a synthetic bone substitute designed recalled by Acumed
Acumed is recalling OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and, distributed in 9 states. The recall was initiated on 5 Dec 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1019-2017
- FDA event ID
- 75904
- Recalling firm
- Acumed, Hillsboro, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Dec 2016
- FDA classified
- 12 Jan 2017
- Reported
- 18 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 5 Dec 2016 | Recall initiated by company | |
| 12 Jan 2017 | Classified by FDA | +38 days |
| 18 Jan 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
FloridaIndianaKansasMichiganMissouriNebraskaOhioPennsylvaniaTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
lot 549/12.001. Part number 65-0210-S.
Where was it sold?
distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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