Radiographic Transparency for Certain and External Connection Tapered… — Class II medical device recall Z-0564-2016
Terminated recall by Biomet 3i, LLC, reported 2016-01-06, distributed in CA, CO, FL, HI, IL, MA, MI, MO…. Images contained within radiographic transparency ART 1036 are undersized.
| Recall number | Z-0564-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet 3i, LLC, Palm Beach Gardens, FL, United States |
| Recall initiated | 2015-11-16 |
| Classified | 2015-12-31 |
| Reported by FDA | 2016-01-06 |
| Terminated | 2016-12-14 |
| Distributed | CA, CO, FL, HI, IL, MA, MI, MO, MP, NY, OH, PR, SC, TX, VA, WI, WV |
| Countries outside the US | AU, DE, FR, GR, TW, UY |
| Quantity | 686 |
| Model numbers | 03/13, 1036 |
Product
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Reason for recall
Images contained within radiographic transparency ART 1036 are undersized.
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-0564-2016. 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.