—#104878

Product

"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF AC4425***Conical 25 ANGLED ABUTMENT***4.1mm(D) X 4mm(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.

FDA product code: NHA — Abutment, Implant, Dental, Endosseous
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K063403
Affected lot / code info: Model AC4425, Lot 887628-5

Why it was recalled

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 (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Biomet 3i, LLC
Address: 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Chile, Italy, Japan, Korea, Spain, and Sweden.

Timeline

Recall initiated: 2011-09-28
Posted by FDA: 2011-11-03
Terminated: 2012-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104878. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.