ENDOBON XENOGRAFT GRANULES 0 — Class III medical device recall Z-1233-2014
Terminated recall by Biomet 3i, LLC, reported 2014-03-26, distributed in CA, DC, FL, HI, LA, MA, MO, NC…. Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have a
| Recall number | Z-1233-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet 3i, LLC, Palm Beach Gardens, FL, United States |
| Recall initiated | 2013-10-03 |
| Classified | 2014-03-19 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2014-12-11 |
| Distributed | CA, DC, FL, HI, LA, MA, MO, NC, NJ, NY, TX, VA, WA |
| Countries outside the US | AT, BE, CA, CH, DE, ES, FR, GB, IE, MX, PL, PT, SG |
| Quantity | 704 |
| Reason classes | labeling |
| Lot numbers | S0171051 |
| Model numbers | ROX05 |
Product
ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
Reason for recall
Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
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-1233-2014. 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.