Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the footprint of the implant, manufact
FDA device recall Z-0776-2014 · posted 2014-01-16 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- Handles and heads may not be compatible.
- Action taken
- The firm, SpineFrontier, sent an "URGENT Arena-L Trials Voluntary Recall Notification" letter dated September 24, 2013 sent to its consignee/customer. The letter described the product, problem and actions to be taken. The consignee/customer were instructed to confirm receipt of the notice and contact Customer Service to initiate the immediate return of the listed parts. In addition, consignee/customer were instructed to complete a recall ACKNOWLEDGEMENT FORM and return it to SpineFrontier via fax to: Attention: Customer Service at 978-232-3991 or email to: customerservice@spinefrontier.com. Please feel free to contact us at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.
- Root cause
- Other
- Status
- Terminated
- Product code
- HTE
- Quantity affected
- 23 devices in total
- Distribution
- US Distribution: VA only.
- Date initiated
- 2013-09-24
- Date posted
- 2014-01-16
- Date terminated
- 2016-08-04
- Location
- Beverly, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.