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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet 3i Narrow Right Angle Large Driver Tip (Hexed)

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  Class 2 Device Recall Biomet 3i Narrow Right Angle Large Driver Tip (Hexed) see related information
Date Initiated by Firm August 10, 2015
Date Posted November 12, 2015
Recall Status1 Terminated 3 on October 12, 2016
Recall Number Z-0266-2016
Recall Event ID 72368
Product Classification dental and restorative instrument - Product Code NDP
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.
Code Information Model # RASH3N Lot # 1184555
Recalling Firm/
Manufacturer		 Biomet 3i, LLC
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
For Additional Information Contact Mark Mashburn
800-443-8166
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
Action 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.
Quantity in Commerce 96 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, Hong Kong, Ireland, Italy, South Korea, and Kuwait.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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