Recall Z-1212-2010 ยท DZE Implant, Endosseous, Root-Form
Pro-Dex Inc dba Dyna-Dent
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.
| Date | Mar 26, 2010 (initiated Jan 19, 2009) |
| Status | Terminated |
| 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. |
| 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 | 70 |
| Distribution | Nationwide distribution: CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991283 | DYNA TORQ TORQUE WRENCH, TORQUE WRENCH Micro Motors, Inc., Aug 18, 1999 |