FDA Medical Device Recalls (openFDA)
MTI Precision Products LLC.: Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
- Recall number
- Z-2044-2014
- Recalling firm
- MTI Precision Products LLC.
- Product
- Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
- Status
- Terminated
- Initiated
- 2012-05-07
- Posted
- 2014-07-12
- Terminated
- 2015-03-12
- Reason
- Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
- Root cause
- Software design (manufacturing process)
- Action
- MTI notified their customers via e-mail on 5/712 and 5/8/12. MTI sent end-users recall letters on or about 5/9/12.
- Quantity
- 134 devices
- Distribution
- US Nationwide Distribution in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.
- Lot, serial or model codes
- P/N Lynx TM20-4H-01: T41202012, T41202013, T41203001, T41203002, T41203003, T41203010, T41204001 to T41204006 P/N Lynx TM20-4H-03 distributed to end user accounts with serial number T41204001 P/N Lynx TM20-2H-03 distributed to Medidenta private labeled as "Meditorque I 20 K" with serial numbers M21203001 to M21203025. P/N Lynx distirbuted to Medidenta private labeled as "Meditorque I 20 K" with serial numbers M21203026 to M21203055. P/N Lynx TM20-4H-01 distributed to Johnson-Promident with serial numbers T41204001-T41204020 P/N Lynx TM20-2H-01 distirbuted to Johnson-Promident with serial numbers T21204001-T21204020.
- 510(k) numbers
- ["K940261"]
- PMA numbers
- not on file
- Product code
- EFB
- Firm FEI
- 2246821
- Firm city
- Lakewood
- Firm state
- NJ
- 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