BIOMET 3i — Class II medical device recall Z-0591-2016
Terminated recall by Biomet 3i, LLC, reported 2016-01-13, distributed nationwide. Inadequate biocompatibility testing.
| Recall number | Z-0591-2016 |
|---|---|
| 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 | 2015-09-21 |
| Classified | 2016-01-05 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-10-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CA, CL, CN, CO, CR, DE, DO, ES, FR, GB, HK, IE, IL, IN, KR, KW, LT, MX, NL, PT, SA, SE, SG, TW, VE, ZA |
| Quantity | 30,111 devices |
| Lot numbers | 1003033, 1004138, 1009002, 1032456, 1032473, 1033485, 1034852, 1035364, 1038519, 1038520, 1045556, 1046268, 1053562, 1053563, 1053564, 1053860, 1054512, 1054540, 1057790, 1059416, 1059512, 1065495, 1065497, 1065507, 1069998, 1069999, 1071165, 1071167, 1071762, 1071763, 1071764, 1071765, 1073161, 1073163, 1086562, 1088470, 1088473, 1088475, 1104109, 1104110 and 46 more |
| Model numbers | PPC484, PPC485, PPC654, PPC655 |
Product
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
Reason for recall
Inadequate biocompatibility testing.
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-0591-2016. 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.