Recall Z-1019-2017— Acumed LLC
Class II · Terminated
Class II FDA medical device recall by Acumed LLC, initiated 2016-12-05, terminated 2017-03-22. It names one FDA 510(k) clearance: K042340. 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: 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..
- Recalling firm
- Acumed LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-05
- Terminated
- 2017-03-22
- Firm location
- Hillsboro, OR, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.