Recalls / —

—#86570

Product

Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.

FDA product code

DZE — Implant, Endosseous, Root-Form

Device class

Class 2

Medical specialty

Dental

510(k) numbers

K061410

Affected lot / code info

Lots 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067 and 61341224.

Why it was recalled

The devices may not meet specifications, which may result in fracturing during tightening of the component.

Root cause (FDA determination)

Process control

Action the firm took

User accounts were notified of the issue by phone on or about 11/6/09. Clinicians were requested to schedule a follow-up appointment and to remove and replace the recalled components for any patients who had this device placed without fracturing during the procedure. Questions are directed to the company at 1-800-854-7019.

Recalling firm

Firm

Zimmer Inc.

Address

345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern

Ohio, Canada and France.

Timeline

Recall initiated

2009-11-06

Posted by FDA

2009-12-10

Terminated

2010-10-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #86570. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.