Z-2072-2017 Class II Terminated
FDA device recall Z-2072-2017 was initiated by Eden Spine Europe SA on March 17, 2017 and is designated Class II. Reason for recall: Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw. The recall status is terminated (terminated January 6, 2020). Affected quantity: 1,839.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- March 17, 2017
- Termination Date
- January 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,839
Product Description
GIZA Vertebral Body Replacement
Reason for Recall
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Distribution Pattern
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
Code Information
Part # 48291482S Cage Giza Diam 14mm, 18-22 mm, 2-5 Deg GTIN 07640167930012 Part # 48291485S Cage Giza Diam 14mm, 18-22 mm, 5-8Deg GTIN 07640167930029 Part # 48291422S Cage Giza Diam 14mm, 23-32 mm, 2-5 Deg GTIN 07640167930036 Part # 48291427S Cage Giza Diam 14mm, 23-32 mm, 7-10 Deg GTIN 07640167930043 Part # 48291432S Cage Giza Diam 14mm, 33-54 mm, 2-5 Deg GTIN 07640167930050 and Part # 48291437S Cage Giza Diam 14mm, 33-54 mm, 7-10 Deg GTIN 07640167930067