Recall Z-1494-2021
Coltene Whaledent Inc · initiated March 18, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot/Batch number: K39841
Reason for recall
The incorrect dental pins were packaged and subsequently distributed.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1494-2021
- Initiated
- March 18, 2021
- Product code
- EBL – Pin, Retentive And Splinting, And Accessory Instruments
- 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.
- Recalling firm
- Coltene Whaledent Inc, Cuyahoga Falls, OH