Z-0266-2016 Class II Terminated
FDA device recall Z-0266-2016 was initiated by Biomet 3I, LLC on Aug 10, 2015 and is designated Class II. 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"… The recall status is terminated (terminated Oct 12, 2016). Affected quantity: 96 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 18, 2015
- Initiation Date
- Aug 10, 2015
- Termination Date
- Oct 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 pieces
Product Description
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.
Distribution Pattern
AK, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KY, LA, MA, MD, MI, MS, NC, NE, NJ, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and District of Columbia Argentina, Australia, Belgium, Canada, Colombia, Greece, Hong Kong, Ireland, Italy, South Korea, and Kuwait.
Code Information
Model # RASH3N Lot # 1184555
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0266-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026