"***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 Recall Z-0158-2012 · Posted 2011-11-03
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Recalling FirmBiomet 3i, LLC
Recall StatusTerminated
Product CodeNHA
Date Initiated2011-09-28
Date Terminated2012-03-09
Product Quantity122
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Chile, Italy, Japan, Korea, Spain, and Sweden.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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