Health product recall

TMS LINK PLUS Self-Threading Pins (2021-03-15)

Starting date:
March 15, 2021
Posting date:
April 14, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75377



Last updated:
2021-04-14

Affected Products 

TMS LINK PLUS Self-Threading Pins

Reason

The incorrect dental pins were packaged and subsequently distributed. The 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, meaning that drills a hole too large for the pins and the pins will not engage the hole to effectively sheer.

Affected products

TMS LINK PLUS Self-Threading Pins

Lot or serial number

K39841

Model or catalog number

L741

Companies
Manufacturer

Coltene/Whaledent, Inc.

235 Ascot Parkway

Cuyahoga Falls

44223

Ohio

UNITED STATES