Z-2140-2019Class II

CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 -

Name: Z-2140-2019 CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 -
Creator: Biomet 3i, LLC
Published: 2019-02-26
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2019-02-26 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous... on 2019-02-26. FDA classified it as Class II and gives the reason as "During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop". 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-2140-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-26
Posted: 2019-08-02
Terminated: 2020-06-15
Recalling firm: ZimVie US Corp LLC
Product: CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm disseminated the notices by email on 02/26/2019. The letter requested that the dental laboratories quarantine and return any unused product and to further notify the affected clinician referral.
Quantity in commerce: 3 units
Distribution: Nationwide and Puerto Rico, Canada, and Australia
Product codes and lots: Lot Numbers/UDI: 8442784-1/(01)00844868031130(10)8442784-1, 8442469-1/(01)00844868031130(10)8442469-1, 8442689-1/(01)00844868031130(10)8442689-1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2140-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2140-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2141-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2142-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2143-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2144-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02

Product code NHA

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)