Osseotite and Nanotite Implants (2013-08-26)

Starting date:

August 26, 2013

Posting date:

November 7, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-36615

• Reason
• Affected products

Recalled Products

A. Full Osseotite Certain Micromini Implant
B. Osseotite XP Certain IOS Implant
C. Certain Prevail Implant
D. Nanotite Certain Microminiplant
E. Nanotite Certain Implant
F. Nanotite Tapered Certain Implant
G. Nanotite Tapered Certain Prevail Implant
H. Osseotite Microminiplant Dental Implant
I. Osseotite Wide Diameter Dental Implant
J. Osseotite Nt Implant Dental Implant
K. Osseotite Certain 2 Implant
L. Osseotite Certain Prevail 2 Implant
M. T3 Prevail Tapered Implant

Reason

A visually observable condition which may be present on some of the implants have been identified. The condition is caused by the implant coming into contact with residual machining fluid which may have been left on the packaging insert. The condition does not meet the cleanliness criteria of Biomet 3i.

Affected products