FDAMarch 17, 2017device
GIZA Vertebral Body Replacement
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
What to do
FDA enforcement status: Terminated
Brands named
eden spine europe saedeneden spine
UPCs
076401679300120764016793002907640167930036076401679300430764016793005007640167930067
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm, 010-107-1411/Small 7 Degree 14mm X 11mm, 010-107-1613/Small 7 Degree 16mm X 13mm, 010-113-1006/Small, 13 Degree 10mm X 6mm, ...2026-04-23
- FDAOxoid Agglutinating Sera, Salmonella 9-0 R309573012026-03-25
- FDAProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.2026-03-20
- FDAProdisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.2026-03-20
- FDAATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use i...2026-01-02
- FDAATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use i...2026-01-02
- FDABrand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No2025-12-31
- FDAEskay Brands Mint flavored tablets. 40mg 7OH/550mg Tablet- Eskay Brands-Mint, Chewable tablet, no shelf-life. Dosage: 2 doses per tablet. 10,000 or less per bulk bag. Bulk package and is not sold directly to consumer.2025-09-09
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