GIZA Vertebral Body Replacement — Class II medical device recall Z-2072-2017
Terminated recall by Eden Spine Europe SA, reported 2017-05-24, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw
| Recall number | Z-2072-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eden Spine Europe SA, Geneva, Switzerland |
| Recall initiated | 2017-03-17 |
| Classified | 2017-05-12 |
| Reported by FDA | 2017-05-24 |
| Terminated | 2020-01-06 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY |
| Quantity | 1,839 |
| UPC / GTIN / UDI-DI | 07640167930012, 07640167930029, 07640167930036, 07640167930043, 07640167930050, 07640167930067 |
| Model numbers | 48291422S, 48291427S, 48291432S, 48291437S, 48291482S, 48291485S |
Product
GIZA Vertebral Body Replacement
Reason for recall
Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2072-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.