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