🔍 RecallPedia

SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only

Class I - Dangerous
🏥 Medical Devices Recalled: January 17, 2020 Ormco/Sybronendo Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All Lots UDI #s: 00889989002652 & 00889989002669
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Ormco/Sybronendo
Reason for Recall:
The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only

Product Codes/Lot Numbers:

All Lots UDI #s: 00889989002652 & 00889989002669

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1257-2020

Related Recalls

SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only

Ormco/Sybronendo

Class I - Dangerous

The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.

Jan 17, 2020 Other Medical Devices Nationwide View Details →

Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.

Ormco/Sybronendo

Class I - Dangerous

Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).

Dec 27, 2017 Diagnostic Equipment Nationwide View Details →