U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Filler, bone void, calcium compound - Product Code MQV
원인
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.
조치
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 returned:
Domestic Customers: please contact Acumed Agent Inventory via email at Agentlnventory@acumed.net or contact your agent directly to be assigned a Return Material Authorization (RMA) number and applicable shipping information.
International Customers: please contact Acumed Business Services via email at BusinessServices@acumed.net or via phone at (877) 627-9957 Option 4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US
and Canada) to be assigned a Return Material Authorization (RMA) number and applicable shipping information.
6. Once completed, please return the OPT Croutons that have been removed to Acumed using the Return Label provided by Acumed and included in your replacement shipment.
Please contact Acumed Business Services via email at BusinessServices@acumed.net or via phone at (877) 627-9957 Option
4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US and Canada) with any questions regarding this notification.
distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
제품 설명
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.