***REF INT411***OSSEOTITE Tapered Certain Implant 4 x 11.5mm***Sterile Using Radiation***Rx Only***BIOMET 3i Dental lber

FDA device recall Z-2245-2011 · posted 2011-05-24 · Terminated

Recall details

Recalling firm

Biomet 3i, LLC

Reason for recall

Biomet 3i is recalling their product Osseotite NT Certain Dental Implant INT411 . The internal thread was not manufactured correctly.

Action taken

Biomet 3i, LLC sent an Urgent Medical Device Recall letter dated March 14, 2011, via email or fax to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A small percentage of the implant lots may have a condition affecting the internal thread. The condition, if present, will prevent the cover screw, temporary healing abutment, final restorative abutment, etc. from engaging the implant. Customers were instructed to contact Customer Service at 1-800-342-5454 if this condition is recognized upon attempting to assemble any of the screws with the implant. Customers were instructed to return the implant to the firm for replacement to the following address: BIOMET 3i Regulatory Compliance Department 4555 Riverside Drive Palm Beach Gardens, Florida 33410 Incident No. CC117886 Customers were also instructed to respond with the attached Response Fax or email to DomesticComplaints@Biomet.com. For any questions regarding this recall call 561-776-6906.

Root cause

Other

Status

Terminated

Product code

O-FY

Quantity affected

236

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Europe, Japan, Asia, and South America.

Date initiated

2011-03-10

Date posted

2011-05-24

Date terminated

2012-01-25

Location

Palm Beach Gardens, FL