—#140807

Product

Biomet 3i Narrow Right Angle Square Driver Tip. 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.

FDA product code: NDP — Accessories, Implant, Dental, Endosseous
Device class: Class 1
Medical specialty: Dental
Affected lot / code info: Model # RASQ3N Lot # 1184554

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Biomet 3i, LLC
Address: 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

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.

Timeline

Recall initiated: 2015-08-10
Posted by FDA: 2015-11-12
Terminated: 2016-10-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.