FDA Device recall Z-0266-2016
Biomet 3i Narrow Right Angle Large Driver Tip (Hexed)
- FDA Device
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of Biomet 3i Narrow Right Angle Large Driver Tip (Hexed) by Biomet 3i, citing 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 lase….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0266-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-10 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet 3i |
| Distribution | 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 |
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
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.
Identifiers
| code_info | Model # RASH3N Lot # 1184555 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0266-2016%22
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