FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1019-2017
- 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.
- Status
- Terminated
- Initiated
- 2016-12-05
- Posted
- not on file
- Terminated
- 2017-03-22
- 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 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
- 83 units distributed in the US
- Distribution
- distributed in FL, IN, KS, MI, MO, NE, OH, PA, TX and Peurto Rico.
- Lot, serial or model codes
- lot 549/12.001. Part number 65-0210-S.
- 510(k) numbers
- ["K042340"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 1000125930
- Firm city
- Hillsboro
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28