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U.S. Department of Health and Human Services

Class 2 Device Recall OPT Croutons synthetic bone substitute

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  Class 2 Device Recall OPT Croutons synthetic bone substitute see related information
Date Initiated by Firm December 05, 2016
Create Date August 23, 2017
Recall Status1 Terminated 3 on March 22, 2017
Recall Number Z-1019-2017
Recall Event ID 75904
510(K)Number K042340  
Product Classification Filler, bone void, calcium compound - Product Code MQV
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.
Code Information lot 549/12.001. Part number 65-0210-S.
Recalling Firm/
Manufacturer		 Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9432
For Additional Information Contact Acumed Business Service
877-627-9957 Ext. 4
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 83 units distributed in the US
Distribution distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = KASIOS BIOMATERIALS
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