Z-0159-2012

"BIOMET 3i4555 Riverside Drive Palm Beach Gardens FL 33410 USAREF SWCA62Conical Abutment Gold...

Name: Z-0159-2012 "***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment Gold...
Creator: Biomet 3i, LLC
Published: 2011-09-28
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2011-09-28 / Terminated / root cause: manufacturing process

FDA source

Biomet 3i, LLC began a recall of "***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment; Pilier... on 2011-09-28. The reason FDA records is "On 09/28/2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Conical Angled Abutment, Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478. The packaging for...". 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-0159-2012
Status: Terminated
Initiated: 2011-09-28
Posted: 2011-11-03
Terminated: 2012-03-09
Recalling firm: ZimVie US Corp LLC
Product: "***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***". Attach an implant to an implant restoration.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: On 09/28/2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Conical Angled Abutment, Model # AC4425 Lot 887628-5 and their Standard Conical Abutment Cylinder Model # SWCA62 Lot 848478. The packaging for the referenced products may not have been completely sealed prior to shipment.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Biomet 3i, LLC sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were asked to inspect their inventory and return any affected product for replacement. A Product Recall Response Form was attached for customers to complete and return via fax to 561-514-6316. Customers are directed to call 1-800-342-5454 for questions regarding this recall.
Quantity in commerce: 8
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Chile, Italy, Japan, Korea, Spain, and Sweden.
Product codes and lots: Model SWCA62, Lot 848478

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