FDA Recall Terminated

Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 The Dental Torque Wrench is used to fasten dental implant abutments during the placement of dental implants.

Recall: Z-1212-2010 · Initiated January 19, 2009

Recall

Recall Number
Z-1212-2010
Event Number
53430
Firm
Pro-Dex Inc dba Dyna-Dent
FEI Number
2081135
Product Code
DZE
Status
Terminated
Root Cause
Error in labeling
Initiated
January 19, 2009
Posted
March 26, 2010
Terminated
July 6, 2011
Address
2361 McGaw Ave, Irvine, CA, 92614-5831

Description

Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 The Dental Torque Wrench is used to fasten dental implant abutments during the placement of dental implants.

Reason

Pro-Dex has initiated a recall on their Dental Torque Wrench. The recall was initiated due to an inaccurate laser etch identification of the torque value.

Action

A "Voluntary Firm Initiated Recall" letter dated January 22, 2009, was sent to the customer. The letter describes the product, problem and action to be taken by the customer. The customer should immediately cease distribution or use of the noted lot; evaluate inventory and distribution records to ensure that this lot is removed from any potential point of use, and return the product to Returns Department at Pro-Dex, Inc . and include the RMA number on the shipping box. If you have any questions or concerns regarding this matter, please call (949) 769-3200.

Distribution

Nationwide distribution: CA

Quantity

70