Ormco/Sybronendo recalls SnapLink dental devices with slide doors that may not stay closed, potentially causing tooth rotation and treatment delays. Affected units include specific model numbers and lots.
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.
Ormco/Sybronendo is recalling SnapLink dental devices where the slide doors might not stay closed. This could cause tooth rotation, delay treatment, and extend procedures by 1-3 months if not fixed.
The slide doors may not stay closed, leading to broken or damaged buccal tubes. If this happens, the tooth could rotate, causing treatment delays and inconvenience for both patients and clinicians.
Dental professionals using SnapLink devices with the specific model and lot numbers listed. Patients receiving treatment with these devices may experience delays.
Check for the model number 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2. Affected units were made in Mexico with specific lot numbers: UDI #s 00889989002652 and 00889989002669.
Verify the model number and lot numbers listed in the recall notice to confirm if your device is affected.
The recall is due to complaints about slide doors not staying closed, which could cause tooth rotation and treatment delays.
Patients using affected devices may experience treatment delays of 1-3 months if the issue is not addressed.
Check the model and lot numbers against the recall list to determine if your device is affected.
We’ve drafted a message you can send Ormco/Sybronendo to request your refund or repair — edit it as you like.
Subject: Recall Z-1258-2020 — Ormco/Sybronendo Ormco/Sybronendo Hello, I own a Ormco/Sybronendo that is covered by recall Z-1258-2020 from Ormco/Sybronendo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
