Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components

FDA device recall Z-0267-2016 · posted 2015-11-12 · Terminated

Recall details

Recalling firm

Biomet 3i, LLC

Reason for recall

RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser marking "RASH3N" during manufacturing.

Action taken

Beginning on or about 08/10/2015 customers will be notified in writing via FEDEX and instructed to to check their inventory for the identified product and to return any unused quantiles along with the recall response. Biomet 3i will promptly issue replacement product.

Root cause

Labeling mix-ups

Status

Terminated

Product code

NDP

Quantity affected

103 pieces

Distribution

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, Ho

Date initiated

2015-08-10

Date posted

2015-11-12

Date terminated

2016-10-12

Location

Palm Beach Gardens, FL