Z-0266-2016Class II

Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit...

Name: Z-0266-2016 Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit...
Creator: Biomet 3i, LLC
Published: 2015-08-10
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2015-08-10 / Terminated / root cause: labeling and UDI

FDA source

Biomet 3i, LLC began a recall of 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... on 2015-08-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0266-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-10
Posted: 2015-11-12
Terminated: 2016-10-12
Recalling firm: ZimVie US Corp LLC
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.
Product code: NDP Accessories, Implant, Dental, Endosseous
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Model # RASH3N Lot # 1184555

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0266-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0266-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-12
Z-0267-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-18	2015-11-12

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)