Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xp
FDA device recall Z-2836-2016 · posted 2016-09-16 · Terminated
Recall details
- Recalling firm
- Ormco/Sybronendo
- Reason for recall
- SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.
- Action taken
- The firm, Kerr, sent an "Urgent: Medical Device Recall" letter dated 8/31/16 to its customers. The letter describes the product, problem and actions to be taken. The customer were instructed to contact SybronEndo Customer Care at (800) 537-7123 to receive a RMA number if they have any of the affected product; and to complete and email back the enclosed acknowledgement form to Sealapex.Response@kerrdental.com , even if they do not have any of the affected product. If you have any questions, call 714-516-7802 or email to: mark.dzendzel@syndrondental.com.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KIF
- Quantity affected
- 179 units
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
- Date initiated
- 2016-08-31
- Date posted
- 2016-09-16
- Date terminated
- 2017-09-01
- Location
- Glendora, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEALAPEX 4 (K010940) | Sybron Dental Specialties, Inc. | 2001-06-20 |