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U.S. Department of Health and Human Services

Class 2 Device Recall TMS LINK PLUS SelfThreading Pins

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 Class 2 Device Recall TMS LINK PLUS SelfThreading Pinssee related information
Date Initiated by FirmMarch 18, 2021
Create DateApril 26, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1494-2021
Recall Event ID 87645
Product Classification Pin, retentive and splinting, and accessory instruments - Product Code EBL
ProductDental 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
Code Information Lot/Batch number: K39841
FEI Number 2416455
Recalling Firm/
Manufacturer		 Coltene Whaledent Inc
235 Ascot Pkwy
Cuyahoga Falls OH 44223-3701
For Additional Information ContactNancy Spencer
330-916-8995
Manufacturer Reason
for Recall		The incorrect dental pins were packaged and subsequently distributed.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce65 packs of 20 pins
DistributionWorldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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