Recall Z-2072-2017 ยท MQP Spinal Vertebral Body Replacement Device
Eden Spine Europe SA
GIZA Vertebral Body Replacement
| Date | Mar 17, 2017 |
| Status | Terminated |
| Reason | Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw. |
| Root cause | Labeling design |
| Action | A correction letter to the users was sent on March 28, 2017 Stating the following: Eden Spine Europe has become aware of extremely rare incidents of disassembly of Giza devices, which is distributed by Stryker Spine in the USA. These incidents have occurred in limited situations when a surgeon has needed to unscrew the device in order to readjust the distraction. To mitigate this risk, a more precise description of the unlocking procedure in the Giza Surgical Technique was added to prevent surgeons from fully unscrewing the locking screw. POTENTIAL HAZARD In the unlikely event the Giza de |
| Quantity | 1,839 |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112429 | GIZA(R) VERTEBRAL BODY REPLACEMENT Eden Spine, LLC, Jan 26, 2012 |