FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1212-2010
- Recalling firm
- Pro-Dex Inc dba Dyna-Dent
- 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.
- Status
- Terminated
- Initiated
- 2009-01-19
- Posted
- 2010-03-26
- Terminated
- 2011-07-06
- 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
- Lot, serial or model codes
- PTW 421 (Lot IZCRQ)
- 510(k) numbers
- ["K991283"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 2081135
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28