BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4 — Class II medical device recall Z-0832-2017
Terminated recall by Biomet 3i, LLC, reported 2016-12-28. A limited number of product pouches may not have been sealed during packaging.
| Recall number | Z-0832-2017 |
|---|---|
| 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 | 2016-09-14 |
| Classified | 2016-12-20 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2019-07-26 |
| Countries outside the US | AT, BE, CH, DE, ES, FR, GB, IE, IT, LT, PT, SE |
| Quantity | 431 |
| Lot numbers | 2015111372, 2016020101, 2016050131, 201611713 |
| Model numbers | ILPAC4330 |
Product
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Reason for recall
A limited number of product pouches may not have been sealed during packaging.
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-0832-2017. 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.