Recall Z-0777-2014
SpineFrontier, Inc. · initiated September 24, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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) and to be inserted into the intervertebral disc space. The Trial Handle consists of a knurled handle and cylindrical shaft with an M4 threads interface at the distal end; 17-4 Stainless steel is used as the material for the handles. The Trial Heads distract the disc space to the surgeon's desired height to gauge which size implant should be utilized to complete the Anterior Lumbar Interbody Fusion Procedure.
Codes / lots: 2572401, 2572402, 2572405, 05172, 2572403, 2572404
Reason for recall
Handles and heads may not be compatible.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-0777-2014
- Initiated
- September 24, 2013
- Posted by FDA
- January 16, 2014
- Terminated
- August 4, 2016
- Product code
- HTE – Elevator
- Quantity
- 23 devices in total
- Distribution
- US Distribution: VA only.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0776-2014 Class II | Arena-L Trial Handle; Part: 11-81002 The trial heads are smooth plates that mimic the…Handles and heads may not be compatible. | 09/24/2013Terminated |
| Z-0778-2014 Class II | Arena-L 38x28Trial Head I 10 Lordotic; Part: 11-81012-08, 11-81012-10, 11-81012-12…Handles and heads may not be compatible. | 09/24/2013Terminated |