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U.S. Department of Health and Human Services

Class 3 Device Recall Zimmer Dental Torque Wrench

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  Class 3 Device Recall Zimmer Dental Torque Wrench see related information
Date Initiated by Firm January 19, 2009
Date Posted March 26, 2010
Recall Status1 Terminated 3 on July 06, 2011
Recall Number Z-1212-2010
Recall Event ID 53430
510(K)Number K991283  
Product Classification torque wrench - Product Code DZE
Product 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.
Code Information PTW 421 (Lot IZCRQ)
Recalling Firm/
Manufacturer		 Pro-Dex Inc dba Dyna-Dent
2361 McGaw Ave
Irvine CA 92614-5831
For Additional Information Contact
714-546-4045
Manufacturer 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.
FDA Determined
Cause 2		 Error in labeling
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.
Quantity in Commerce 70
Distribution Nationwide distribution: CA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = MICRO MOTORS, INC.
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