Recall Z-1019-2017 ยท MQV Filler, Bone Void, Calcium Compound
Acumed LLC
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.
| Date | Dec 5, 2016 |
| 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. |
| Root cause | Vendor change control |
| Action | Acumed sent the Urgent Recall Notice letter, dated December 1, 2016, to US customers on December 5, 2016. Customers are advised to follow the instructions provided by Acumed: IMMEDIATELY stop using and/or distributing the product and complete the following actions: 1. Perform a physical count of your inventory. 2. Remove the affected OPT Croutons, such that the croutons are out of service. 3. Record this data on the survey found following this recall letter. 4. Fill out the survey and return it via email to RecaiiNotification@acumed.net. 5. For any product that needs to be r |
| Quantity | 83 units distributed in the US |
| Distribution | distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042340 | KASIOS TCP Kasios Biomaterials, Nov 24, 2004 |