FDA Medical Device Recalls (openFDA)
Coltene Whaledent Inc: Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741
- Recall number
- Z-1494-2021
- Recalling firm
- Coltene Whaledent Inc
- Product
- Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741
- Status
- Open, Classified
- Initiated
- 2021-03-18
- Posted
- not on file
- Terminated
- not on file
- Reason
- The incorrect dental pins were packaged and subsequently distributed.
- Root cause
- Under Investigation by firm
- Action
- On 3/18/2021, Coltene issued an Urgent Medical Device Recall notice via letter to customers notifying them the incorrect dental pins were packaged and subsequently distributed. The TMS LINK PLUS Self-Threading L741 Pins should be stainless steel, single sheer link pins that are gold-plated. The pins that were packed and distributed are titanium, double sheer, and not gold plated. The incorrectly packaged pin is too small for the drill, resulting in a hole that may be drilled too large for the pins. The pins may not engage the hole to effectively sheer.
- Quantity
- 65 packs of 20 pins
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.
- Lot, serial or model codes
- Lot/Batch number: K39841
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EBL
- Firm FEI
- 2416455
- Firm city
- Cuyahoga Falls
- Firm state
- OH
- 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