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.
FDA Recall Z-1212-2010 · Posted 2010-03-26
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Recalling FirmPro-Dex Inc dba Dyna-Dent
Recall StatusTerminated
Product CodeDZE
Date Initiated2009-01-19
Date Terminated2011-07-06
Product Quantity70
Reason for Recall
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Nationwide distribution: CA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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