Z-1257-2020Class II

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

Name: Z-1257-2020 SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE...
Creator: Ormco/Sybronendo
Published: 2020-01-17
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2020-01-17 / Terminated / root cause: design

FDA source

Ormco/Sybronendo began a recall of 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 on 2020-01-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1257-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-17
Posted: 2020-02-06
Terminated: 2024-09-30
Recalling firm: Ormco/Sybronendo
Product: 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 code: DZD Tube, Orthodontic
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.
Root cause tag: design
FDA root cause: Device Design
Action: ISSUE: Ormco received an increase in complaints relating to lower Snaplink buccal tube slide doors not staying closed. We received 140 complaints from 2015 to Sep 2019, with no reported patient injuries. The incidence of this issue appears to be low. Approximately <0.1% of the Snaplink Buccal Tubes experience this issue due to an interaction between the Snaplink slide and the pin that enables the door to stay open or closed. RISK: In the event of functional failure, broken/damaged Snaplink may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If a patient or clinician does not notice this issue, it may extend treatment by approximately 1-3 months, depending on the patients visit schedule. If you experience this failure, please follow the recommendations below. RECOMMENDATION: Ormco is not requesting removal of Snaplink, from your facility. You can continue to use the product in your inventory. If you experience Snaplink buccal tube slide doors not staying closed, Ormco requests you to: (1) Call Ormco customer service at 1-800-854-1741 or email [email protected] to log any complaints related to this issue. (2) For patients who had Snaplink lowers placed, check the patient records and determine if you need an additional patient visit to check the integrity of the door to ensure it remains closed. (3) Instruct patients to check bracket after each brush to ensure bracket door remains closed. If door appears open, instruct patients to contact your office to schedule an appointment. (4) If the bracket door does not stay closed, use a double over tie, per typical orthodontic practices (Refer to pictures below) or remove the Snaplink and replace it with a new device. If the Snaplink is removed, please contact customer care (1-800-854-1741) for the product to be returned. (5) Complete the enclosed acknowledgement form and email the form to [email protected] within 10 business days. If
Quantity in commerce: 3,632,493 brackets
Distribution: US:AK,AL,AR,AZ,CA,CO,CN,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,SD,TN,TX,UT,VA,VT,WA,WI,WV,WY OUS: Argentina, Australia, Barbados, Bahamas, Bolivia, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Hong Kong, Indonesia, Japan, Cambodia, Korea, Cayman Islands, Sri Lanka, Myanmar, Mexico, Malaysia, Netherlands, Nepal, Panama, Philippines, Paraguay, Russian Federation, Singapore, Thailand, Taiwan, Uruguay, Viet Nam, South Africa
Product codes and lots: All Lots UDI #s: 00889989002652 & 00889989002669

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1257-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1257-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-18
Z-1258-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-18

Product code DZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)