Biomet 3i Narrow Right Angle Large Driver Tip — Class II medical device recall Z-0266-2016
Terminated recall by Biomet 3i, LLC, reported 2015-11-18, distributed in AK, AZ, CA, CO, CT, DC, FL, GA…. The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment
| Recall number | Z-0266-2016 |
|---|---|
| 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 | 2015-08-10 |
| Classified | 2015-11-12 |
| Reported by FDA | 2015-11-18 |
| Terminated | 2016-10-12 |
| Distributed | AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MS, NC, NE, NJ, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA |
| Countries outside the US | AR, AU, BE, CA, CO, GR, HK, IE, IT, KR, KW |
| Quantity | 96 units |
| Reason classes | labeling |
| Lot numbers | 1184555 |
| Model numbers | RASH3N |
Product
Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal. For dental and restorative procedures.
Reason for recall
The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.
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-0266-2016. 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.