Recall Z-0777-2014 ยท HTE Elevator
SpineFrontier, Inc.
Arena-L 35x26 Trial Head I 10 Lordotic; Part: 11-81004-08, 11-81004-10, 11-81004-12, 11-81004-14, 11-81004-16 The trial heads are smooth plates that mimic the footprint of the implant, manufactured from 17-4 Stainless Steel into 35X26mm (11-81004-XX) and 38X28mm (11-81012-XX) varieties, each with multiple height configurations. The Trial Heads are intended to attach tot he Trial Handle (11-81002)
| Date | Jan 16, 2014 (initiated Sep 24, 2013) |
| Status | Terminated |
| Reason | Handles and heads may not be compatible. |
| Root cause | Other |
| Action | 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. |
| Quantity | 23 devices in total |
| Distribution | US Distribution: VA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.