Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provid
FDA device recall Z-1871-2013 · posted 2013-08-02 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference.
- Action taken
- Spine Frontier sent an Advisory Notice dated November 9, 2012, via email to all affected customers. Customers were advised that their FacetFuse Drill Guides need to be replaced. Customers were instructed to write their number ( included in the email) on the outside of the package and provide us with the tracking information. A replacement part has been sent out to you. If you have any further questions please call (978) 232-3990.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FZX
- Quantity affected
- 13 drill guides
- Distribution
- US Distribution including Puerto Rico and the states of CO, KS, MA and TX.
- Date initiated
- 2012-11-09
- Date posted
- 2013-08-02
- Date terminated
- 2015-06-05
- Location
- Beverly, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHAMELEON FIXATION SYSTEM (K071420) | Spinefrontier, Inc. | 2008-01-16 |