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Recall Observatory FDA recall evidence

Device 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.

Z-0267-2016

August 10, 2015

Class II

Product summary

Firm
Biomet 3i, LLC
Event
Event 72368
Status
Terminated
Classification
Class II
Quantity
103 pieces
Official record key
device-enforcement:Z-0267-2016

Official wording

Reason: 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.

Code information: Model # RASQ3N Lot # 1184554

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.