Recall Z-1871-2013 ยท FZX Guide, Surgical, Instrument
SpineFrontier, Inc.
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to measure depth that the drills and taps are protruding into bone, which is measur
| Date | Aug 2, 2013 (initiated Nov 9, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 13 drill guides |
| Distribution | US Distribution including Puerto Rico and the states of CO, KS, MA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071420 | CHAMELEON FIXATION SYSTEM Spinefrontier, Inc., Jan 16, 2008 |