Z-0842-2017Class II

BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a...

Name: Z-0842-2017 BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a...
Creator: Biomet 3i, LLC
Published: 2016-09-14
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2016-09-14 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly... on 2016-09-14. FDA classified it as Class II and gives the reason as "A limited number of product pouches may not have been sealed during packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0842-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-14
Posted: 2016-12-20
Terminated: 2019-07-26
Recalling firm: ZimVie US Corp LLC
Product: BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: A limited number of product pouches may not have been sealed during packaging.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: BIOMET 3i will conduct this recall with Dentists and Health Care Professionals. Notices will be sent via a carrier with a traceable method of delivery by BIOMET 3i team members. " All dentists and health care professionals will be notified via courier: - Dentists and health care professionals will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their control. - Dentists and health care professionals will return on-hand product to BIOMET 3i via a courier agency and ensure all of their products are accounted for using the form provided in the letter. - Dentists and health care professionals will complete and return the Inventory Return Certification Form to the fax number or email address provided. International distributors will be notified via email. Further distribution of the international customer notices will be sent through the local and regional distributors following local language translation. Communications will occur as translations are completed and are anticipated to occur during the week of September 12, 2016.1233. Customers with questions were instructed to call the customer call center at +44 (0) 800 652-1233.
Quantity in commerce: 46
Distribution: Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Product codes and lots: Part # ILPC443U Lot # 2015120624

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0842-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0828-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0829-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0830-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0831-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0832-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0833-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0834-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0835-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0836-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0837-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0838-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0839-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0840-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0841-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0842-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0843-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0844-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0845-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0846-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0847-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0848-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0849-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0850-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0851-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0852-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0853-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0854-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0855-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0856-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0857-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0858-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0859-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0860-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0861-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0862-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20
Z-0863-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-20

Product code NHA

K092341Class IILow Profile Abutments - Internal and External ConnectionBiomet 3i, Inc. / cleared 2009-11-30

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)