Z-1212-2010

Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 The Dental Torque Wrench is...

Name: Z-1212-2010 Zimmer PTW4321 20 Ncm Dental Torque Wrench, QTY 1 Pro-Dex Inc, Irvine, CA 92614 The Dental Torque Wrench is...
Creator: Pro-Dex Inc dba Dyna-Dent
Published: 2009-01-19
License: https://open.fda.gov/license/

Pro-Dex Inc / initiated 2009-01-19 / Terminated / root cause: labeling and UDI

FDA source

Pro-Dex Inc dba Dyna-Dent began a recall of 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... on 2009-01-19. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1212-2010
Status: Terminated
Initiated: 2009-01-19
Posted: 2010-03-26
Terminated: 2011-07-06
Recalling firm: Pro-Dex Inc
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.
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: PTW 421 (Lot IZCRQ)

Product code DZE

K991283Class IIDyna Torq Torque Wrench, Torque WrenchMicro Motors, Inc. / cleared 1999-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)