Reported Jan 18, 2017 · Terminated
OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium…
Acumed LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acumed LLC · 5885 NW Cornelius Pass Rd · Hillsboro, OR · 97124-9432
Is this the product you have?
- 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.
- Lot codes and dates
- lot 549/12.001. Part number 65-0210-S.
- Amount recalled
- 83 units distributed in the US
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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