Reported May 24, 2017 · Terminated
GIZA Vertebral Body Replacement
Eden Spine Europe SA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Eden Spine Europe SA · rue du 31 Decembre 41 · Geneva · N/A
Is this the product you have?
- GIZA Vertebral Body Replacement
- Lot codes and dates
- 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
- Amount recalled
- 1,839
Where it was sold
Why it was recalled
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
This product could cause temporary or reversible health problems — stop using it.
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