lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
FDA device recall Z-0977-2015 · posted 2015-01-14 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
- Action taken
- Spinefrontier sent an Urgent Voluntary Recall Notification letter dated December 16, 2015, to all affected customers. The notice informed customers of the recall and requests that they initiate the immediate return of the parts listed. In addition, SpineFrontier is requiring confirmation via recall acknowledgement form that consignees have received this notice and that they will initiated the immediate return of the parts. Customers can contact SpineFrontier at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 4 devices
- Distribution
- Nationwide Distribution including TX, OH, VA, and Washington, DC.
- Date initiated
- 2014-12-19
- Date posted
- 2015-01-14
- Date terminated
- 2016-01-11
- Location
- Beverly, MA
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