Monday, May 14, 2012

Important information for 3i implant users.


Biomet 3i— Full OSSEOTITE Certain Tapered Implants: Internal Hex May Be Too Shallow, Potentially Preventing Implant Engagement

Dental Implants, Endosteal, Root Form [23565];
Product Identifier:
Full OSSEOTITE Certain Tapered Implants [Consumable]
Product No. IFNT611; Lot No. 2011110798
Geographic Regions: (Impact in additional regions has not been identified or ruled out at the time of this posting), U.K., U.S.
Manufacturer(s): Biomet 3i LLC [452929], 4555 Riverside Dr, Palm Beach Gardens, FL 33410, United States
Problem:
In a March 19, 2012, Urgent Medical Device Recall letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Biomet 3i states that a manufacturing defect may cause the internal hex of the above implants to be too shallow, potentially preventing the driver, cover screw, or abutment from fully engaging the implant. Biomet 3i states that if an implant with the shallow hex defect was successfully placed, the subsequent healing or restorative abutment will not correctly engage. Biomet 3i states that if the abutment is correctly seated on the implant, the defect is not present and the implant is not affected. Biomet 3i states that use of affected product is not expected to result in adverse health events. The manufacturer has not confirmed the information provided in the source material.
Action Needed:
Verify that you have received the March 19, 2012, Urgent Medical Device Recall letter and product recall response form from Biomet 3i. Identify and isolate any affected product in your inventory. To arrange for product replacement at no charge, return unopened or unused affected product, labeled with "incident no. CMP-20055," to Biomet 3i, Attn: P.M. Regulatory Compliance, at the address above. Contact the Biomet 3i customer service department by telephone at (800) 342-5454 within the U.S. or your Biomet local representative for assistance if the mating component does not fully engage with successfully placed affected product. Regardless of whether you have affected product, complete the product recall response form and return it to Biomet 3i by fax at (561) 514-6316.
For Further Information:
Biomet 3i customer assistance department
Tel.: (800) 342-5454

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