Z-1366-2008

BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm...

Name: Z-1366-2008 BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm...
Creator: Biomet 3i, Inc.
Published: 2008-02-14
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2008-02-14 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, Inc. began a recall of BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL on 2008-02-14. The reason FDA records is "Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform)". 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-1366-2008
Status: Terminated
Initiated: 2008-02-14
Posted: 2008-03-29
Terminated: 2008-07-10
Recalling firm: ZimVie US Corp LLC
Product: BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4.1mm(D) X 5mm(P) X 3mm(H), Sterile, BIOMET 3i, Palm Beach, FL
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform)
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Each USA customer was first contacted by telephone and then with a faxed, Urgent Medical Device Recall letter, dated 2/25/2008. Each International customer was first contacted by E-mail and then with a faxed letter. They were instructed to return the affected product to Biomet 3i.
Quantity in commerce: 254
Distribution: Worldwide
Product codes and lots: Lot Number: 770147

Product code NHA

K072642Class IIBiomet 3I Dental Abutments and Restorative ComponentsBiomet 3i, Inc. / cleared 2007-12-20

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)