Z-1019-2017Class II

OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure...

Name: Z-1019-2017 OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure...
Creator: Acumed LLC
Published: 2016-12-05
License: https://open.fda.gov/license/

Acumed LLC / initiated 2016-12-05 / Terminated / root cause: supplier

FDA source

Acumed LLC began a recall of 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... on 2016-12-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1019-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-05
Posted: 2017-08-23
Terminated: 2017-03-22
Recalling firm: Acumed LLC
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.
Product code: MQV Filler, Bone Void, Calcium Compound
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.
Root cause tag: supplier
FDA 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 [email protected]. 5. For any product that needs to be returned: Domestic Customers: please contact Acumed Agent Inventory via email at [email protected] 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 [email protected] 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 [email protected] 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.
Product codes and lots: lot 549/12.001. Part number 65-0210-S.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1019-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1019-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-12

Product code MQV

K042340Class IIKasios TcpKasios Biomaterials / cleared 2004-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)