Biomet 3i, LLC: Medical Device Recall in 2015 - (Recall #: Z-0266-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 10, 2015

Date Posted: November 18, 2015

Recall Number: Z-0266-2016

Event ID: 72368

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.

Status: Terminated

Product Quantity: 96 pieces

Code Information:

Model # RASH3N Lot # 1184555

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.

Voluntary or Mandated:

Voluntary: Firm initiated